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 IDK972183
510k NumberK972183
Device Name:DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant ACE MEDICAL CO. 2260 EAST EL SEGUNDO BLVD. Los Angeles,  CA  90245
ContactKathleen A Dragovich
CorrespondentKathleen A Dragovich
ACE MEDICAL CO. 2260 EAST EL SEGUNDO BLVD. Los Angeles,  CA  90245
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-10
Decision Date1997-08-26
Summary:summary

NIH GUDID Devices

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