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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, spinal intervertebral body
510(k) Number K101255
Device Name ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM
Applicant
ALPHATEC SPINE, INC.
5818 EL CAMINO REAL
CARLSBAD,  CA  92008
Applicant Contact KARLA SCHAFFNER
Correspondent
ALPHATEC SPINE, INC.
5818 EL CAMINO REAL
CARLSBAD,  CA  92008
Correspondent Contact KARLA SCHAFFNER
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received05/04/2010
Decision Date 07/21/2010
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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