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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthosis, spinal pedicle fixation
510(k) Number K073143
Device Name MODIFIED VERTIFLEX SPINAL SCREW SYSTEM
Original Applicant
VERTIFLEX, INC.
1351 calle avanzado
san clemente,  CA  92673
Original Contact steve reitzler
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
MNH   NKB  
Date Received11/07/2007
Decision Date 04/07/2008
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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