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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sacroiliac Joint Fixation
510(k) Number K221050
Device Name ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema 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 Number888.3040
Classification Product Code
OUR  
Subsequent Product Codes
KWP   KWQ   NKG  
Date Received04/11/2022
Decision Date 06/30/2022
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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