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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name spinal vertebral body replacement device - cervical
510(k) Number K151651
Device Name NuVasive X-CORE Mini Cervical Expandable VBR System
Applicant
NUVASIVE, INCORPORATED
7475 LUSK BLVD.
san diego,  CA  92121
Applicant Contact olga lewis
Correspondent
NUVASIVE, INCORPORATED
7475 LUSK BLVD.
san diego,  CA  92121
Correspondent Contact olga lewis
Regulation Number888.3060
Classification Product Code
PLR  
Date Received06/18/2015
Decision Date 09/25/2015
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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