CurvaFix® IM Implant CRS-095-110-02
GUDID 10855068008003
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.
Curvafix Inc
Arthrodesis nail, sterile| Primary Device ID | 10855068008003 |
| NIH Device Record Key | 1a5beb8e-564b-44c6-9dcf-adbed5438af1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CurvaFix® IM Implant |
| Version Model Number | 9.5 MM x 110 MM, Self Tapping |
| Catalog Number | CRS-095-110-02 |
| Company DUNS | 039779098 |
| Company Name | Curvafix Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com |
Device Dimensions
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 110 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10855068008003 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180050
FDA Product Code
| HSB | Rod, Fixation, Intramedullary And Accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-19 |
| Device Publish Date | 2021-08-11 |
On-Brand Devices [CurvaFix® IM Implant]
| 10855068008102 | The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra |
| 10855068008096 | The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra |
| 10855068008089 | The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra |
| 10855068008072 | The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra |
| 10855068008065 | The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra |
| 10855068008058 | The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra |
| 10855068008041 | The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra |
| 10855068008034 | The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra |
| 10855068008027 | The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra |
| 10855068008010 | The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra |
| 10855068008003 | The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra |
| 10855068008720 | The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra |
| 10855068008713 | The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra |
| 10855068008706 | The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra |
| 10855068008690 | The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra |
| 10855068008683 | The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra |
| 10855068008676 | The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra |
| 10855068008669 | The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra |
| 10855068008652 | The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra |
| 10855068008645 | The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra |
| 10855068008638 | The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra |
Trademark Results [CurvaFix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CURVAFIX 86297392 5503301 Live/Registered |
CURVAFIX, INC. 2014-06-02 |
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