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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 K130917
Device Name HEALIX ADVANCE KNOTLESS BR ANCHOR
Applicant
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
325 PARAMOUNT DR.
RAYNHAM,  MA  02767
Applicant Contact YAYOI FUJIMAKI
Correspondent
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
325 PARAMOUNT DR.
RAYNHAM,  MA  02767
Correspondent Contact YAYOI FUJIMAKI
Regulation Number888.3030
Classification Product Code
MAI  
Date Received04/03/2013
Decision Date 05/24/2013
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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