DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL

Rod, Fixation, Intramedullary And Accessories

ACE MEDICAL CO.

The following data is part of a premarket notification filed by Ace Medical Co. with the FDA for Depuy Ace A.i.m. Titanium Tibial Nail.

Pre-market Notification Details

• Device ID: K972183
• 510k Number: K972183
• Device Name: DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: ACE MEDICAL CO. 2260 EAST EL SEGUNDO BLVD. Los Angeles, CA 90245
• Contact: Kathleen A Dragovich
• Correspondent: Kathleen A Dragovich; ACE MEDICAL CO. 2260 EAST EL SEGUNDO BLVD. Los Angeles, CA 90245
• Product Code: HSB
• CFR Regulation Number: 888.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-06-10
• Decision Date: 1997-08-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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