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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 K121176
Device Name STGC
Applicant
CARDINAL SPINE, LLC
11234 EL CAMINO REAL,
SUITE 200
san diego,  CA  9213
Applicant Contact kevin a thomas
Correspondent
CARDINAL SPINE, LLC
11234 EL CAMINO REAL,
SUITE 200
san diego,  CA  9213
Correspondent Contact kevin a thomas
Regulation Number888.3060
Classification Product Code
MQP  
Date Received04/18/2012
Decision Date 08/17/2012
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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