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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name appliance, fixation, spinal interlaminal
510(k) Number K122509
Device Name VERTIFLEX SPINOUS PROCESS FIXATION PLATE
Original Applicant
VERTIFLEX, INC.
1351 calle avanzado
san clamente,  CA  92673
Original Contact steve reitzler
Regulation Number888.3050
Classification Product Code
KWP  
Date Received08/17/2012
Decision Date 12/17/2012
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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