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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 K142030
Device Name STGC-LORDOTIC
Applicant
CARDINAL SPINE, LLC
12264 EL CAMINO REAL,
SUITE 400
SAN DIEGO,  CA  92130
Applicant Contact KEVIN A. THOMAS
Correspondent
CARDINAL SPINE, LLC
12264 EL CAMINO REAL,
SUITE 400
SAN DIEGO,  CA  92130
Correspondent Contact KEVIN A. THOMAS
Regulation Number888.3060
Classification Product Code
MQP  
Date Received07/25/2014
Decision Date 01/23/2015
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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