Cleared Traditional

BIOMET CABLE SYSTEM

K071271 · Biomet Manufacturing, Inc. · Orthopedic
Oct 2007
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K071271 is an FDA 510(k) clearance for the BIOMET CABLE SYSTEM, a Cerclage, Fixation (Class II — Special Controls, product code JDQ), submitted by Biomet Manufacturing, Inc. (Warsaw,, US). The FDA issued a Cleared decision on October 23, 2007, 169 days after receiving the submission on May 7, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number K071271 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2007
Decision Date October 23, 2007
Days to Decision 169 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDQ — Cerclage, Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3010

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