CurvaFix® Low Profile Implant

Basic Information

• Brand Name: CurvaFix® Low Profile Implant
• Primary DI: 10850070500323
• Version / Model: 7.5 mm x 160 mm
• Catalog Number: CRS-075-160-LP
• Company Name: CURVAFIX, INC.
• Labeler DUNS: 039779098
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-22
• Public Version: 2
• Public Version Date: 2026-04-06
• Public Version Status: Update
• Public Device Record Key: 4accd1c8-6d37-430a-b48b-55dccd93fe7b

Device Description

The CurvaFix® Low Profile 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. If explantation is required, the Implant can be unlocked into a flexible state before removal. Supplied individually on a backer card in sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWC	Screw, Fixation, Bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66947	Orthopaedic bone screw (non-sliding)	A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10850070500323	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K252019	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	7.5	Millimeter
Length	160	Millimeter