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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 K982662
Device Name DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW
Applicant
DePuy Orthopaedics, Inc.
P.O. Box 988
Warsaw,  IN  46581 -0988
Applicant Contact SALLY FOUST
Correspondent
DePuy Orthopaedics, Inc.
P.O. Box 988
Warsaw,  IN  46581 -0988
Correspondent Contact SALLY FOUST
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Codes
MAI   MBI  
Date Received07/30/1998
Decision Date 10/28/1998
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
Recalls CDRH Recalls
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