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FDA 510(k) Application Details - K123993
Device Classification Name
More FDA Info for this Device
510(K) Number
K123993
Device Name
SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
Applicant
ALPHATEC SPINE, INC.
5818 EL CAMINO REAL
CARLSBAD, CA 92008 US
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Contact
TREVOR DENBO
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
OVD
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More FDA Info for this Product Code
Date Received
12/26/2012
Decision Date
03/05/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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