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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 K122352
Device Name NUVASIVE PRECEPT SPINAL SYSTEM
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 Received08/03/2012
Decision Date 09/11/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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