RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT— 510(k) K964472

Name: FDA 510(k) clearance K964472
Creator: U.S. Food and Drug Administration
Published: 1997-02-03

Substantially Equivalent

Biologically Oriented Prostheses

FDA 510(k) clearance K964472 for RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT, Substantially Equivalent on 1997-02-03. Applicant: Biologically Oriented Prostheses. Device class: 2.

Clearance details

Applicant: Biologically Oriented Prostheses
Product code: Code KYI
Device class: Class 2
Regulation: 21 CFR 888.3770
Advisory panel: Orthopedic
Date received: 1996-11-07
Decision date: 1997-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Huron, MI, US

Download summary PDF View on FDA.gov ↗

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