Cleared Traditional

DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS

K070292 · Zimmer GmbH · Orthopedic
Apr 2007
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K070292 is an FDA 510(k) clearance for the DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS, a Prosthesis, Hip, Femoral, Resurfacing (Class II — Special Controls, product code KXA), submitted by Zimmer GmbH (Warsaw, US). The FDA issued a Cleared decision on April 26, 2007, 85 days after receiving the submission on January 31, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3400.

Submission Details

510(k) Number K070292 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2007
Decision Date April 26, 2007
Days to Decision 85 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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