Southern Transforaminal Lumbar Interbody Fusion (TLIF)

Intervertebral Fusion Device With Bone Graft, Lumbar

Southern Medical (Pty) Ltd

The following data is part of a premarket notification filed by Southern Medical (pty) Ltd with the FDA for Southern Transforaminal Lumbar Interbody Fusion (tlif).

Pre-market Notification Details

Device IDK221182
510k NumberK221182
Device Name:Southern Transforaminal Lumbar Interbody Fusion (TLIF)
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Southern Medical (Pty) Ltd 55 Regency Drive, Route 21 Corporate Park Irene,  ZA 0178
ContactDalene Styger
CorrespondentNathan Wright
Empirical Technologies 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-25
Decision Date2022-12-08

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