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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 K200995
Device Name Insignia™ Anterior Cervical Plate System
Applicant
Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad,  CA  92008
Applicant Contact Sandy Gill
Correspondent
Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad,  CA  92008
Correspondent Contact Sandy Gill
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received04/16/2020
Decision Date 05/21/2020
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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