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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K972629
Device Name DEPUY AE TK2 HIP SCREW SYSTEM
Applicant
Depuy, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581 -0988
Applicant Contact KATHLEEN A DRAGOVICH
Correspondent
Depuy, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581 -0988
Correspondent Contact KATHLEEN A DRAGOVICH
Regulation Number888.3030
Classification Product Code
KTT  
Date Received07/14/1997
Decision Date 10/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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