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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 K223719
Device Name Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System
Applicant
Aegis Spine, Inc.
9781 S. Meridian Blvd., Suite 300
Englewood,  CO  80112
Applicant Contact Kihyang Kim
Correspondent
Aegis Spine, Inc.
9781 S. Meridian Blvd., Suite 300
Englewood,  CO  80112
Correspondent Contact Kihyang Kim
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received12/12/2022
Decision Date 01/11/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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