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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name rod, fixation, intramedullary and accessories
510(k) Number K013563
Device Name LONG TROCHANTERIC NAIL SYSTEM
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DR.
warsaw,  IN  46581 -0988
Applicant Contact marcia j arentz
Correspondent
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DR.
warsaw,  IN  46581 -0988
Correspondent Contact marcia j arentz
Regulation Number888.3020
Classification Product Code
HSB  
Date Received10/26/2001
Decision Date 12/27/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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