Cleared Traditional

DEPUY ROCKWOOD CLAVICLE PIN

K991649 · Depuy, Inc. · Orthopedic
Jul 1999
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K991649 is an FDA 510(k) clearance for the DEPUY ROCKWOOD CLAVICLE PIN, a Pin, Fixation, Threaded (Class II — Special Controls, product code JDW), submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 14, 1999, 62 days after receiving the submission on May 13, 1999. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K991649 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 1999
Decision Date July 14, 1999
Days to Decision 62 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDW — Pin, Fixation, Threaded
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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