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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K132014
Device Name GSB GLOBAL SPINAL BALANCE 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 Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received07/01/2013
Decision Date 10/31/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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