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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, fixation, bone
510(k) Number K122005
Model MXL
Device Name MAXLOCK EXTREME SYSTEM
Original Applicant
ORTHOHELIX SURGICAL DESIGNS, INC.
1065 medina rd.
suite 500
medina,  OH  44256
Original Contact derek lewis
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received07/09/2012
Decision Date 09/06/2012
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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