DEPUY AE TK2 HIP SCREW SYSTEM

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

DEPUY, INC.

The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Ae Tk2 Hip Screw System.

Pre-market Notification Details

Device IDK972629
510k NumberK972629
Device Name:DEPUY AE TK2 HIP SCREW SYSTEM
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw,  IN  46581 -0988
ContactKathleen A Dragovich
CorrespondentKathleen A Dragovich
DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw,  IN  46581 -0988
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-07-14
Decision Date1997-10-09
Summary:summary

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