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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, nondegradable, soft tissue
510(k) Number K122123
Device Name 6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED
Applicant
DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY
325 Paramount Drive
Raynham,  MA  02767
Applicant Contact JULIE VAFIDES
Correspondent
DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY
325 Paramount Drive
Raynham,  MA  02767
Correspondent Contact JULIE VAFIDES
Regulation Number888.3040
Classification Product Code
MBI  
Date Received07/18/2012
Decision Date 10/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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