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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with integrated fixation, cervical
510(K) Number K122630
Device Name IN:C2 SPINAL FIXATION SYSTEM
Applicant
SPINE SMITH PARTNERS L.P.
93 red river
austin,  TX  78701
Contact clifton (chris) naivar
Regulation Number888.3080
Classification Product Code
OVE  
Date Received08/28/2012
Decision Date 12/05/2012
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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