TLIF

GUDID 06009527200263

Tlif Camber, Size 35 Height 13

SOUTHERN MEDICAL (PTY) LTD

Polymeric spinal interbody fusion cage
Primary Device ID06009527200263
NIH Device Record Key1903ad81-628d-408e-a7dd-928b4baaff13
Commercial Distribution StatusIn Commercial Distribution
Brand NameTLIF
Version Model NumberTLIF-C-35-13
Company DUNS567466073
Company NameSOUTHERN MEDICAL (PTY) LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106009527200263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-30
Device Publish Date2026-03-20

On-Brand Devices [TLIF ]

06009527200263Tlif Camber, Size 35 Height 13
06009527200256Tlif Camber, Size 35 Height 12
06009527200249Tlif Camber, Size 35 Height 07
06009527200232Tlif Camber, Size 30, Height 13
06009527200225Tlif Camber, Size 30, Height 12
06009527200218Tlif Camber, Size 30, Height 11
06009527200164Tlif Camber, Size 30, Height 10
06009527200157Tlif Camber, Size 30, Height 09
06009527200140Tlif Camber, Size 30, Height 08
06009527200133Tlif Camber, Size 30, Height 07
06009527200126Tlif Camber, Size 35 Height 11
06009527200119Tlif Camber, Size 35 Height 10
06009527200102Tlif Camber, Size 35 Height 09
06009527200096Tlif Camber, Size 30 Height 08

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.