Timberline Lateral Fusion System

Basic Information

• Brand Name: Timberline Lateral Fusion System
• Primary DI: 03662663277709
• Version / Model: 8738-0503
• Catalog Number: 8738-0503
• Company Name: Highridge Medical, LLC
• Labeler DUNS: 119260394
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-18
• Public Version: 2
• Public Version Date: 2026-03-19
• Public Version Status: Update
• Public Device Record Key: e3aa1c3a-126e-497b-9ca0-f7a4ae1c2ee3

Device Description

ANCHORING PIN 70MM BLADE

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
LXH	Orthopedic manual surgical instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66938	Spinal intraoperative positioning screw	A nonimplantable threaded rod with a screw head and an internal (socket) drive intended to be temporarily screwed into vertebral bone to assist with the positioning of an implantable device (typically a fixation plate) during spinal surgery. The internal drive may be one of a variety of designs (e.g., a slot, or of cross, star, or polygonal shape) for use with an appropriate screwdriver. Once introduced it does not include a rod that protrudes from the vertebral bone (i.e., not a positioning/manipulation pin). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03662663277709	GS1

Customer Contacts

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