Cleared Traditional

DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS

K033329 · Depuy, Inc. · Orthopedic
Nov 2003
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K033329 is an FDA 510(k) clearance for the DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 14, 2003, 29 days after receiving the submission on October 16, 2003. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K033329 FDA.gov
FDA Decision Cleared SESE
Date Received October 16, 2003
Decision Date November 14, 2003
Days to Decision 29 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSB — Rod, Fixation, Intramedullary And Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3020

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