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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Facet Screw Spinal Device
510(k) Number K123218
Device Name ILLICO FS FACET FIXATION SYSTEM
Applicant
Alphatec Spine, Inc.
5830 El Camino Real
Carlsbad,  CA  92008
Applicant Contact TREVOR DENBO
Correspondent
Alphatec Spine, Inc.
5830 El Camino Real
Carlsbad,  CA  92008
Correspondent Contact TREVOR DENBO
Classification Product Code
MRW  
Date Received10/15/2012
Decision Date 11/28/2012
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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