ACE PROXIMAL HUMERAL NAIL SYSTEM

Rod, Fixation, Intramedullary And Accessories

DEPUY ACE

The following data is part of a premarket notification filed by Depuy Ace with the FDA for Ace Proximal Humeral Nail System.

Pre-market Notification Details

• Device ID: K033806
• 510k Number: K033806
• Device Name: ACE PROXIMAL HUMERAL NAIL SYSTEM
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: DEPUY ACE 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Contact: Rhonda Myer
• Correspondent: Rhonda Myer; DEPUY ACE 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: 2003-12-08
• Decision Date: 2004-02-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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