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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 K251965
Device Name Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)
Applicant
Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad,  CA  92008
Applicant Contact Griffin Riggs
Correspondent
Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad,  CA  92008
Correspondent Contact Griffin Riggs
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received06/26/2025
Decision Date 08/28/2025
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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