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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 K090669
Device Name RIGIDFIX BIOCRYL CROSS PIN KITS
Applicant
Depuy Mitek, A Johnson & Johnson Company
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact ZHENG LIU
Correspondent
Depuy Mitek, A Johnson & Johnson Company
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact ZHENG LIU
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
HTY  
Date Received03/13/2009
Decision Date 04/03/2009
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
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