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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, for degenerative disc disease
510(k) Number K121619
Device Name NUVASIVE POLYAXIAL SPINAL SCREWS
Original Applicant
NUVASIVE, INC.
7475 lusk blvd
san diego,  CA  92121
Original Contact elias ketchum
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received06/01/2012
Decision Date 08/24/2012
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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