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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 K231766
Device Name Skyway Anterior Cervical Plate System
Applicant
Kyocera Medical Technologies Inc. (KMTI)
1200 California St.
Suite 210
Redlands,  CA  92374
Applicant Contact Joey Thompson
Correspondent
Empirical Technologies
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number888.3060
Classification Product Code
KWQ  
Subsequent Product Code
OVE  
Date Received06/16/2023
Decision Date 09/12/2023
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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