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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
510(k) Number K142205
Device Name NuVasive X-CORE(R) Expandable VBR System
Applicant
NUVASIVE, INC.
7475 LUSK BLVD.
SAN DIEGO,  CA  92121
Applicant Contact OLGA LEWIS
Correspondent
NUVASIVE, INC.
7475 LUSK BLVD.
SAN DIEGO,  CA  92121
Correspondent Contact OLGA LEWIS
Regulation Number888.3060
Classification Product Code
MQP  
Date Received08/11/2014
Decision Date 02/20/2015
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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