DEPUY ACE VERSANAIL TIBIAL NAIL

Rod, Fixation, Intramedullary And Accessories

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Ace Versanail Tibial Nail.

Pre-market Notification Details

• Device ID: K032097
• 510k Number: K032097
• Device Name: DEPUY ACE VERSANAIL TIBIAL NAIL
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Contact: Tiffani Rogers
• Correspondent: Tiffani Rogers; DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Product Code: HSB
• CFR Regulation Number: 888.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-07-08
• Decision Date: 2003-08-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887868018787	K032097	000
00887868018671	K032097	000
00887868018664	K032097	000
00887868018657	K032097	000
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00887868018596	K032097	000
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00887868018794	K032097	000