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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 K182808
Device Name Aspida® Anterior Lumbar Plating System
Applicant
Alphatec Spine, Inc.
5818 El Camino Real
Carlsnad,  CA  92008
Applicant Contact Ruby Zheng
Correspondent
Alphatec Spine, Inc.
5818 El Camino Real
Carlsnad,  CA  92008
Correspondent Contact Ruby Zheng
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received10/03/2018
Decision Date 11/09/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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