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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name posterior metal/polymer spinal system, fusion
510(K) Number K061774
Device Name NFIX II PEDICLE SCREW SYSTEM
Applicant
N SPINE, INC.
13221 maricotte place
san diego,  CA  92130
Contact r. stephen reitzler
Regulation Number888.3070
Classification Product Code
NQP  
Date Received06/23/2006
Decision Date 12/13/2006
Decision substantially equivalent - with limitations (SU)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
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