curvafix.comCurvaFix IM System
CurvaFix, Inc.
CURVAFIX, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3016537375 | 3016537375 | CURVAFIX, INC. | 1 | N | 2026-01-01 | 10220 Points Dr NE Suite 300 Kirkland WA US 98033 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10850070500125 | CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel. | 4252768800 | support@curvafix.com |
| 10850070500132 | CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel. | 4252768800 | support@curvafix.com |
| 10850070500149 | CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel. | 4252768800 | support@curvafix.com |
| 10850070500156 | CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel. | 4252768800 | support@curvafix.com |
| 10850070500163 | CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel. | 4252768800 | support@curvafix.com |
| 10850070500170 | CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel. | 4252768800 | support@curvafix.com |
| 10850070500187 | CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel. | 4252768800 | support@curvafix.com |
| 10850070500194 | CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel. | 4252768800 | support@curvafix.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 288866 | 1356893642 | K252019 | CurvaFix Low Profile System | HWC | 2025-08-29 |
| 288866 | 1050509301 | K222505 | CurvaFix IM System | HWC | 2022-10-27 |
| 288866 | 1255192286 | K180050 | CurvaFix Intramedullary Rodscrew System | HWC | 2019-03-01 |
| 288866 | 1939458761 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HWC | 3 | 2025-08-29 |
PMN#
CurvaFix Intramedullary Rodscrew System
CurvaFix, Inc.
GUDID#
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix Redirect System Instrument Set - A reusable instrument set consisting of the Redirect Handle, housed in a sterilizable storage container, that is used during a surgical procedure for the CurvaFix Low Profilie Implant. Provided non-sterile; ready for cleaning and steam sterilization at healthcare facility before use; reprocessed after each use.
2026-04-14
Instrument Set (case and Reusable Instruments) - A custom engineered set of reusable surgical instruments, housed in a sterilizable storage container, that are used during a CurvaFix surgical procedure.
2023-01-05
Cannulated Flexible Reamer, 6.0mm - A surgical drilling instrument (6.0mm diameter) intended to be connected to a standard power tool, which is used to open and enlarge the medullary canal for the insertion of the CurvaFix IM Implant during a fracture fixation procedure. This device is cannulated so that it can be fed over a guiding wire that has been placed into the correct position inside the bone prior to operation of the drill.
2022-12-05
Sterilization Tray, Upper - Reusable instrument storage tray housed in the Instrument case that is used to contain the reusable instruments during sterilization processing in preparationfor pelvic fixation procedure
2022-12-05
Sterilization Tray, Lower - Reusable instrument storage tray housed in the instrument case that is used to contain the reusable instruments during sterilization processing in preparation for pelvic fixation procedure.
2022-12-05
Cannulated Step Drill, Small Implant - A cannulated drill bit that attaches to a surgical power tool. It is used over a guide pin to make the initial entry into the pelvic bone.
2022-12-05
Steerable Guide Sleeve, Small Implant - A hand-held tubular surgical device designed to be used during a CurvaFix Implant implantation procedure to facilitate the acceptance of a Steerable Guide through it.
2022-12-05
Implant Selection Device - Reusable surgical measurement instrument used when determining the size of the CurvaFix IM Implant to be used in a pelvic fixation procedure.
2022-12-05
Countersink - A T-handled instrument used to manually enlarge the diameter of the proximal portion of bone canal in preparation for insertion of the CurvaFix Implant.
2022-12-05
CurvaFix® IM Implant - The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. The device is manufactured from Stainless Steel.
2022-12-05
CurvaFix® IM Implant - The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. The device is manufactured from Stainless Steel.
2022-12-05
CurvaFix® IM Implant - The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. The device is manufactured from Stainless Steel.
2022-12-05
CurvaFix® IM Implant - The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. The device is manufactured from Stainless Steel.
2022-12-05
CurvaFix® IM Implant - The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. The device is manufactured from Stainless Steel.
2022-12-05