7.5mm CurvaFix Locking Tool

Basic Information

• Brand Name: 7.5mm CurvaFix Locking Tool
• Primary DI: 10850070500552
• Version / Model: CLA-003-LP
• Catalog Number: CLA-003-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: 24ad8ade-3f95-485b-b78d-b1857cdcfe2a

Device Description

Fits inside 7.5mm Inserter and engages the proximal end of the 7.5 Implant to lock device and convert from a flexible to rigid state. Also used to unlock the 7.5 Implant and convert from a rigid to flexible state if removal is needed.

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
33968	Surgical screwdriver, reusable	A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10850070500552	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K252019	000