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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 K231145
Device Name Axis Anterior Cervical Plate System
Applicant
Southern Medical (Pty) , Ltd.
55 Regency Dr.
Rte. 21 Corporate Park
Irene,  ZA 0178
Applicant Contact Dalene Styger
Correspondent
Empirical Technologies
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received04/21/2023
Decision Date 06/13/2023
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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