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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 K210325
Device Name APOLLO Anterior Cervical Plate (ACP) System
Applicant
Aurora Spine, Inc.
1930 Palomar Point Way, Suite #103
Carlsbad,  CA  92008
Applicant Contact Laszlo Garamszegi
Correspondent
Watershed Idea Foundry
1815 Aston Ave., Suite 106
Carlsbad,  CA  92008
Correspondent Contact Jeffrey Brittan
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received02/04/2021
Decision Date 03/23/2021
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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