CurvaFix® IM Implant CRS-075-160-01

GUDID 10855068008706

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

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 10855068008706
• NIH Device Record Key: f4abdfa8-c0ef-4e35-afb7-3eb108f55770
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CurvaFix® IM Implant
• Version Model Number: 7.5 mm x 160 mm
• Catalog Number: CRS-075-160-01
• Company DUNS: 039779098
• Company Name: Curvafix Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: 4252768800
• Email: support@curvafix.com
• Phone: 4252768800
• Email: support@curvafix.com
• Phone: 4252768800
• Email: support@curvafix.com
• Phone: 4252768800
• Email: support@curvafix.com
• Phone: 4252768800
• Email: support@curvafix.com
• Phone: 4252768800
• Email: support@curvafix.com
• Phone: 4252768800
• Email: support@curvafix.com
• Phone: 4252768800
• Email: support@curvafix.com
• Phone: 4252768800
• Email: support@curvafix.com
• Phone: 4252768800
• Email: support@curvafix.com
• Phone: 4252768800
• Email: support@curvafix.com
• Phone: 4252768800
• Email: support@curvafix.com
• Phone: 4252768800
• Email: support@curvafix.com
• Phone: 4252768800
• Email: support@curvafix.com
• Phone: 4252768800
• Email: support@curvafix.com

Device Dimensions

• Outer Diameter: 7.5 Millimeter
• Length: 160 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 160 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 160 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 160 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 160 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 160 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 160 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 160 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 160 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 160 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 160 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 160 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 160 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 160 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 160 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10855068008706 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222505

FDA Product Code

• HWC: Screw, Fixation, Bone

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: 2022-12-13
• Device Publish Date: 2022-12-05

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