DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS

Rod, Fixation, Intramedullary And Accessories

DEPUY, INC.

The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Ace Universal And Troch Entry Femoral Nail Systems.

Pre-market Notification Details

• Device ID: K033329
• 510k Number: K033329
• Device Name: DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Contact: Rhonda Myer
• Correspondent: Rhonda Myer; DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Product Code: HSB
• CFR Regulation Number: 888.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-10-16
• Decision Date: 2003-11-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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