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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 K060225
Device Name NUVASIVE SPHERX SYSTEM
Applicant
NUVASIVE, INC.
4545 TOWNE CENTRE COURT
san diego,  CA  92121
Applicant Contact laetitia cousin
Correspondent
NUVASIVE, INC.
4545 TOWNE CENTRE COURT
san diego,  CA  92121
Correspondent Contact laetitia cousin
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWQ   NKB  
Date Received01/30/2006
Decision Date 04/12/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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