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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, Lumbar
510(k) Number K221182
Device Name Southern Transforaminal Lumbar Interbody Fusion (TLIF)
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 Number888.3080
Classification Product Code
MAX  
Date Received04/25/2022
Decision Date 12/08/2022
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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