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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 K203154
Device Name KASILOF Cervical Plate System
Applicant
Kahtnu Surgical, Inc.
170 E. Corral Ave. Suite 1
Soldotna,  AK  99669
Applicant Contact Craig Wilcox
Correspondent
MRC Global, LLC
9085 E. Mineral Cir., Suite 110
Centennial,,  CO  80112
Correspondent Contact Ann Dunahoo
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received10/22/2020
Decision Date 11/05/2020
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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