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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Threaded
510(k) Number K954630
Device Name DEPUY TITANIUM CROSS PIN FIXATION SYSTEM
Applicant
Depuy, Inc.
P.O. Box 988
700 Orthopaedic Dr.
Warsaw,  IN  46581
Applicant Contact STEVE WENTWORTH
Correspondent
Depuy, Inc.
P.O. Box 988
700 Orthopaedic Dr.
Warsaw,  IN  46581
Correspondent Contact STEVE WENTWORTH
Regulation Number888.3040
Classification Product Code
JDW  
Date Received10/06/1995
Decision Date 12/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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