Advantage ALIF Trial Cage

GUDID 09348215068066

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215068066
NIH Device Record Keyd4d53fe3-40de-496a-a16e-9b8c15b00665
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdvantage ALIF Trial Cage
Version Model Number132-23-4085
Company DUNS751993028
Company NameSIGNATURE ORTHOPAEDICS 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 Usefalse
Lot Batchtrue
Serial Numberfalse
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
GS109348215068066 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215068066]

Moist Heat or Steam Sterilization


[09348215068066]

Moist Heat or Steam Sterilization


[09348215068066]

Moist Heat or Steam Sterilization


[09348215068066]

Moist Heat or Steam Sterilization


[09348215068066]

Moist Heat or Steam Sterilization


[09348215068066]

Moist Heat or Steam Sterilization


[09348215068066]

Moist Heat or Steam Sterilization


[09348215068066]

Moist Heat or Steam Sterilization


[09348215068066]

Moist Heat or Steam Sterilization


[09348215068066]

Moist Heat or Steam Sterilization


[09348215068066]

Moist Heat or Steam Sterilization


[09348215068066]

Moist Heat or Steam Sterilization


[09348215068066]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-09
Device Publish Date2020-07-01

On-Brand Devices [Advantage ALIF Trial Cage]

09348215068271132-23-5167
09348215068264132-23-5165
09348215068257132-23-5163
09348215068240132-23-5161
09348215068233132-23-5127
09348215068226132-23-5125
09348215068219132-23-5123
09348215068202132-23-5121
09348215068196132-23-5087
09348215068189132-23-5085
09348215068172132-23-5083
09348215068165132-23-5081
09348215068158132-23-4167
09348215068141132-23-4165
09348215068134132-23-4163
09348215068127132-23-4161
09348215068110132-23-4127
09348215068103132-23-4125
09348215068097132-23-4123
09348215068080132-23-4121
09348215068073132-23-4087
09348215068066132-23-4085
09348215068059132-23-4083
09348215068042132-23-4081
09348215068035132-23-3167
09348215068028132-23-3165
09348215068011132-23-3163
09348215068004132-23-3161
09348215067991132-23-3127
09348215067984132-23-3125
09348215067977132-23-3123
09348215067960132-23-3121
09348215067953132-23-3087
09348215067946132-23-3085
09348215067939132-23-3083
09348215067922132-23-3081

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