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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 K963973
Device Name DEPUY CANNULATED CROSS PIN SCREW SYSTEM
Applicant
Depuy, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581
Applicant Contact ARLENE SAULL
Correspondent
Depuy, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581
Correspondent Contact ARLENE SAULL
Regulation Number888.3040
Classification Product Code
JDW  
Subsequent Product Code
HWC  
Date Received10/03/1996
Decision Date 12/16/1996
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
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