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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K070925
Device Name MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR
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
MAI  
Subsequent Product Codes
GAM   GAS   GAT  
Date Received04/03/2007
Decision Date 05/02/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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