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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name screw, fixation, bone
510(K) Number K121349
Device Name IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER
Applicant
EXTREMITY MEDICAL LLC
300 interpace parkway
suite 410
parsippany,  NJ  07054
Contact jamy gannoe
Regulation Number888.3040
Classification Product Code
HWC  
Date Received05/04/2012
Decision Date 07/18/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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