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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthosis, spondylolisthesis spinal fixation
510(k) Number K033546
Device Name NUVASIVE SPINAL SYSTEM
Applicant
NUVASIVE, INC.
10065 OLD GROVE RD.
san diego,  CA  92131
Applicant Contact laetitia bernard
Correspondent
NUVASIVE, INC.
10065 OLD GROVE RD.
san diego,  CA  92131
Correspondent Contact laetitia bernard
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWQ   MNI   NKB  
Date Received11/12/2003
Decision Date 04/12/2004
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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