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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K961234
Device Name DEPUY ADVANTAGE FIXATION SCREW SYSTEM
Applicant
Depuy, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581 -0988
Applicant Contact SALLY FOUST
Correspondent
Depuy, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581 -0988
Correspondent Contact SALLY FOUST
Regulation Number888.3040
Classification Product Code
HWC  
Date Received03/29/1996
Decision Date 06/19/1996
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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