Valeo Fusion System

Basic Information

• Brand Name: Valeo Fusion System
• Primary DI: M555910099002
• Version / Model: A
• Catalog Number: 91.009.9002
• Company Name: SINTX Technologies, Inc.
• Labeler DUNS: 028629553
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-29
• Public Version: 8
• Public Version Date: 2026-03-20
• Public Version Status: Update
• Public Device Record Key: 4f97b62d-d1a8-43c0-9152-da6ce53c9f5f

Device Description

Valeo VBR Trial Caddy

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61300	Internal spinal fixation procedure kit, single-use	A collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M555910099002	HIBCC

Customer Contacts

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