Cleared Traditional

BIOPRO TARA FEMORAL RESURFACING COMPONENT

K043542 · Biopro, Inc. · Orthopedic
May 2005
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K043542 is an FDA 510(k) clearance for the BIOPRO TARA FEMORAL RESURFACING COMPONENT, a Prosthesis, Hip, Femoral, Resurfacing (Class II — Special Controls, product code KXA), submitted by Biopro, Inc. (Port Huron, US). The FDA issued a Cleared decision on May 18, 2005, 146 days after receiving the submission on December 23, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3400.

Submission Details

510(k) Number K043542 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2004
Decision Date May 18, 2005
Days to Decision 146 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KXA — Prosthesis, Hip, Femoral, Resurfacing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3400

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