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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with integrated fixation, lumbar
510(k) Number K102402
Device Name SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM
Applicant
ALPHATEC SPINE, INC.
5818 EL CAMINO REAL
CARLSBAD,  CA  92008
Applicant Contact MARY STANNERS
Correspondent
ALPHATEC SPINE, INC.
5818 EL CAMINO REAL
CARLSBAD,  CA  92008
Correspondent Contact MARY STANNERS
Regulation Number888.3080
Classification Product Code
OVD  
Date Received08/24/2010
Decision Date 03/30/2011
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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