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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
Models 254652, 254653, 254654
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
Original Applicant
DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY
325 paramount drive
raynham,  MA  02767
Original Contact julie vafides
Regulation Number888.3040
Classification Product Code
MBI  
Date Received07/18/2012
Decision Date 10/02/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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