RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT

Prosthesis, Wrist, Carpal Trapezium

BIOLOGICALLY ORIENTED PROSTHESES

The following data is part of a premarket notification filed by Biologically Oriented Prostheses with the FDA for Riopro Cobalt Trapeziometarcarpal Resurfacing Component.

Pre-market Notification Details

• Device ID: K964472
• 510k Number: K964472
• Device Name: RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT
• Classification: Prosthesis, Wrist, Carpal Trapezium
• Applicant: BIOLOGICALLY ORIENTED PROSTHESES 17 SEVENTEENTH ST. Port Huron, MI 48060
• Contact: Valerie Gardner
• Correspondent: Valerie Gardner; BIOLOGICALLY ORIENTED PROSTHESES 17 SEVENTEENTH ST. Port Huron, MI 48060
• Product Code: KYI
• CFR Regulation Number: 888.3770 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-11-07
• Decision Date: 1997-02-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M209142720	K964472	000
M209142620	K964472	000
M209142630	K964472	000
M209142640	K964472	000
M209142650	K964472	000
M209142680	K964472	000
M209142690	K964472	000
M209142700	K964472	000
M209142710	K964472	000
M209142600	K964472	000