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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 K120589
Model 6X15MM, 7X15MM AND 8X15MM
Device Name MILAGRO INTERFERENCE SCREWS
Original Applicant
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
325 paramount dr.
raynham,  MA  02767
Original Contact deep pal
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
HWC  
Date Received02/28/2012
Decision Date 04/24/2012
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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