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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 K042325
Device Name TROCHANTERIC NAIL SYSTEM
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
warsaw,  IN  46581 -0988
Applicant Contact steve kahn
Correspondent
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
warsaw,  IN  46581 -0988
Correspondent Contact steve kahn
Regulation Number888.3020
Classification Product Code
HSB  
Date Received08/27/2004
Decision Date 09/08/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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