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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K130105
Device Name RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM
Applicant
Depuy Mitek, A Johnson & Johnson Company
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact JULIE VAFIDES
Correspondent
Depuy Mitek, A Johnson & Johnson Company
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact JULIE VAFIDES
Regulation Number888.3040
Classification Product Code
HTY  
Subsequent Product Code
MAI  
Date Received01/15/2013
Decision Date 05/17/2013
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
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