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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 K210035
Device Name ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System
Applicant
Aegis Spine
9781 S. Meridian Blvd, Ste 300
Englewood,  CO  80112
Applicant Contact Kay Kwon
Correspondent
Empirical Testing Corp.
4628 Northpark Drive
Colorado Springs,  CO  80918
Correspondent Contact Meredith Lee May
Regulation Number888.3040
Classification Product Code
OUR  
Subsequent Product Codes
KWP   KWQ   NKG  
Date Received01/06/2021
Decision Date 02/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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