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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 K112249
FOIA Releasable 510(k) K112249
Device Name HEALIX KNOTLESS(TM) ANCHOR
Applicant
Depuy Mitek, A Johnson & Johnson Company
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact DEEP PAL
Correspondent
Depuy Mitek, A Johnson & Johnson Company
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact DEEP PAL
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
HWC  
Date Received08/05/2011
Decision Date 10/25/2011
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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