Velofix™ SA Cervical Cage

GUDID 08800037545916

U&I CORPORATION

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage
Primary Device ID08800037545916
NIH Device Record Key9ade88e9-09c3-4b49-aac3-41fff0374623
Commercial Distribution StatusIn Commercial Distribution
Brand NameVelofix™ SA Cervical Cage
Version Model NumberTSA6406
Company DUNS688811082
Company NameU&I CORPORATION
Device Count1
DM Exempttrue
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 Numbertrue
Manufacturing Datefalse
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
GS108800037545916 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral fusion device with integrated fixation, cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


[08800037545916]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-06
Device Publish Date2021-11-26

On-Brand Devices [Velofix™ SA Cervical Cage]

08800015997386TSS1001
08800015995511TS0040
08800037504357TS0050
08800037504340TS0060
08800037507266TSS1001
08800037507259TS0100
08800037507242TS0040
08800037508263TS0130
08800037508256TS0120
08800037508249TS0110
08800037508232TS0030
08800037508225TS0020
08800037508218TS0010
08800037521224TS0070
08800037519771TSA1000
08800015960991RSA1000
08800015960984TSA1000
08800015960977TS4020FD
08800015960960TS4019FD
08800015960953TS4018FD
08800015960946TS4017FD
08800015960939TS4016FD
08800015960922TS4015FD
08800015960915TS4014FD
08800015960908TS4013FD
08800015960892TS4012FD
08800015960885TS4011FD
08800015960878TS4010FD
08800015960861TS3520FD
08800015960854TS3519FD
08800015960847TS3518FD
08800015960830TS3517FD
08800015960823TS3516FD
08800015960816TS3515FD
08800015960809TS3514FD
08800015960793TS3513FD
08800015960786TS3512FD
08800015960779TS3511FD
08800015960762TS3510FD
08800015960755TS4020FT
08800015960748TS4019FT
08800015960731TS4018FT
08800015960724TS4017FT
08800015960717TS4016FT
08800015960700TS4015FT
08800015960694TS4014FT
08800015960687TS4013FT
08800015960670TS4012FT
08800015960663TS4011FT
08800015960656TS4010FT

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.