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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 K063205
Device Name ATLAS SPINE VERTEBRAL BODY REPLACEMENT
Applicant
ATLAS SPINE LLC
11234 EL CAMINO REAL
SUITE 200
san diego,  CA  92130
Applicant Contact floyd g larson
Correspondent
ATLAS SPINE LLC
11234 EL CAMINO REAL
SUITE 200
san diego,  CA  92130
Correspondent Contact floyd g larson
Regulation Number888.3060
Classification Product Code
MQP  
Date Received10/23/2006
Decision Date 02/26/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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