VersiTomic® G-Lok with 45mm Loop

Basic Information

• Brand Name: VersiTomic® G-Lok with 45mm Loop
• Primary DI: 10810190010102
• Version / Model: F
• Catalog Number: tg101045st
• Company Name: T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
• Labeler DUNS: 534123013
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 4
• Public Version Date: 2023-01-16
• Public Version Status: Update
• Public Device Record Key: 914bcc12-0cbe-4fd0-a6d8-f841f2c5fd34

Device Characteristics

• Single Use: Yes
• 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: No
• 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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36174	Ligament bone anchor	A non-bioabsorbable device designed to be implanted into bone specifically to attach the ends of a ligament (synthetic or natural source) to the bone, e.g., during reconstructive knee surgery. The device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10810190010102	GS1

Premarket Submissions

Submission Number	Supplement Number
K101616	000