Cleared Special

RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD

K071053 · Biomet, Inc. · Orthopedic
Jun 2007
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K071053 is an FDA 510(k) clearance for the RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD, a Prosthesis, Hip, Femoral, Resurfacing (Class II — Special Controls, product code KXA), submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 29, 2007, 77 days after receiving the submission on April 13, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3400.

Submission Details

510(k) Number K071053 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2007
Decision Date June 29, 2007
Days to Decision 77 days
Submission Type Special
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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