THUMB MOD HEAD TITANIUM 13MM

Basic Information

• Brand Name: THUMB MOD HEAD TITANIUM 13MM
• Primary DI: M209177980
• Version / Model: 17798
• Company Name: BIOPRO, INC.
• Labeler DUNS: 618749857
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-30
• Public Version: 1
• Public Version Date: 2024-06-07
• Public Version Status: New
• Public Device Record Key: bd761f5c-bc45-4c3d-ae66-b942ca11bafb

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
KYI	Prosthesis, Wrist, Carpal Trapezium	Orthopedic	888.3770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33539	Carpometacarpal interpositional spacer, non-bioabsorbable	A non-bioabsorbable device designed to be implanted into the first carpometacarpal (CMC) joint (i.e., between the trapezium and the first metacarpal bone) to treat pain, instability, and/or motion disabilities of the thumb caused by arthritis. It is typically spherical in shape and made of metal or ceramic.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M209177980	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K061089	000