Tarsa-Link Wedge Fixation System

Basic Information

• Brand Name: Tarsa-Link Wedge Fixation System
• Primary DI: 00190837063535
• Version / Model: 114-160
• Catalog Number: 114-160
• Company Name: Life Spine, Inc.
• Labeler DUNS: 183641617
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-07
• Public Version: 2
• Public Version Date: 2021-06-08
• Public Version Status: Update
• Public Device Record Key: bb799fc3-2125-4aec-ab59-a49de8e6ccb4

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
HRS	Plate, fixation, bone	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61330	Polymeric osteotomy fusion cage, non-customized	A non-customized device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia) following osteotomy to help facilitate bone fusion and alignment; it is typically used with a plating fixation system and may be used in association with a bone substitute/graft. The device is typically designed as a small, wedge-shaped cylinder (or other geometric form) and is made of synthetic polymer [e.g., polyetheretherketone (PEEK)].	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190837063535	GS1

Premarket Submissions

Submission Number	Supplement Number
K150368	000