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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 intervertebral body
510(K) Number K121815
Model MULTIPLE
Device Name NUVASIVE SAGE LATERAL PLATE SYSTEM
Applicant
NUVASIVE, INC.
7475 lusk blvd
san diego,  CA  92121
Contact sheila bruschi
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received06/20/2012
Decision Date 10/23/2012
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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