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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K062170
Device Name BIOKNOTLESS AND LUPINE PLUS ANCHORS
Applicant
Depuy Mitek, A Johnson & Johnson Company
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact KRISTINE CHRISTO
Correspondent
Depuy Mitek, A Johnson & Johnson Company
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact KRISTINE CHRISTO
Regulation Number888.3030
Classification Product Code
JDR  
Subsequent Product Codes
HWC   MAI  
Date Received07/31/2006
Decision Date 08/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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