Low Profile Guidewire Kit

Basic Information

• Brand Name: Low Profile Guidewire Kit
• Primary DI: 10850070500095
• Version / Model: CGK-001-LP
• Catalog Number: CGK-001-LP
• Company Name: CURVAFIX, INC.
• Labeler DUNS: 039779098
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-23
• Public Version: 2
• Public Version Date: 2026-04-06
• Public Version Status: Update
• Public Device Record Key: f6479996-fb10-4684-8b2c-9ed518ace5a2

Device Description

A single use kit, composed of a sterile packaged Steerable Guide, Driving Guidewire and Exchange Tube, that is used during a surgical procedure for the placement of the CurvaFix Low Profile Implant. Supplied in a single sterile barrier package placed in shelf carton.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62729	Orthopaedic guidewire, single-use	A thin, non-implantable rod designed to guide the insertion of a cannulated/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10850070500095	GS1

Customer Contacts

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