Velofix™ TLIF Cage

GUDID 08800308490006

CG MedTech Co.,Ltd.

Surgical implant/trial-implant/sizer holder, reusable
Primary Device ID08800308490006
NIH Device Record Key6788c597-4525-4a69-98c4-76145ccd17aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameVelofix™ TLIF Cage
Version Model NumberTL0230
Company DUNS688811082
Company NameCG MedTech Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800308490006 [Primary]

FDA Product Code

FZXGuide, surgical, instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800308490006]

Moist Heat or Steam Sterilization


[08800308490006]

Moist Heat or Steam Sterilization


[08800308490006]

Moist Heat or Steam Sterilization


[08800308490006]

Moist Heat or Steam Sterilization


[08800308490006]

Moist Heat or Steam Sterilization


[08800308490006]

Moist Heat or Steam Sterilization


[08800308490006]

Moist Heat or Steam Sterilization


[08800308490006]

Moist Heat or Steam Sterilization


[08800308490006]

Moist Heat or Steam Sterilization


[08800308490006]

Moist Heat or Steam Sterilization


[08800308490006]

Moist Heat or Steam Sterilization


[08800308490006]

Moist Heat or Steam Sterilization


[08800308490006]

Moist Heat or Steam Sterilization


[08800308490006]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-24
Device Publish Date2025-03-16

On-Brand Devices [Velofix™ TLIF Cage]

08800308490006TL0230
08800037598257TL0060

Trademark Results [Velofix]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VELOFIX
VELOFIX
86151986 4788231 Live/Registered
Velofix Holdings Ltd.
2013-12-24
VELOFIX
VELOFIX
85885268 4827448 Live/Registered
Velofix Holdings Ltd.
2013-03-25

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.