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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K222806
Device Name Kodiak C Spinal Implant System
Applicant
Met One Technologies, LLC
513 W. San Antonio Ave., Suite C
El Paso,  TX  79901
Applicant Contact Adrian Carbonell
Correspondent
Met One Technologies, LLC
513 W. San Antonio Ave., Suite C
El Paso,  TX  79901
Correspondent Contact Adrian Carbonell
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MQP  
Date Received09/16/2022
Decision Date 12/22/2022
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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