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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pin, fixation, smooth
510(k) Number K120165
Device Name INTRAOSSEOUS FIXATION SYSTEM
Original Applicant
ORTHOHELIX SURGICAL DESIGNS, INC.
1065 medina rd.
suite 500
medina,  OH  44256
Original Contact derek lewis
Regulation Number888.3040
Classification Product Code
HTY  
Date Received02/02/2012
Decision Date 04/17/2012
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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