Brisbane ALIF Cage

GUDID 09348215018481

SIGNATURE ORTHOPAEDICS PTY LTD

Metal-polymer composite spinal interbody fusion cage
Primary Device ID09348215018481
NIH Device Record Key7d24820a-9d62-406c-b32c-37f017e4a239
Commercial Distribution StatusIn Commercial Distribution
Brand NameBrisbane ALIF Cage
Version Model NumberPS1-23-3165
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109348215018481 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-02-24
Device Publish Date2018-01-10

On-Brand Devices [Brisbane ALIF Cage]

09348215018733PS1-23-5167
09348215018726PS1-23-5165
09348215018719PS1-23-5163
09348215018702PS1-23-5161
09348215018696PS1-23-5127
09348215018689PS1-23-5125
09348215018672PS1-23-5123
09348215018665PS1-23-5121
09348215018658PS1-23-5087
09348215018641PS1-23-5085
09348215018634PS1-23-5083
09348215018627PS1-23-5081
09348215018610PS1-23-4167
09348215018603PS1-23-4165
09348215018597PS1-23-4163
09348215018580PS1-23-4161
09348215018573PS1-23-4127
09348215018566PS1-23-4125
09348215018559PS1-23-4123
09348215018542PS1-23-4121
09348215018535PS1-23-4087
09348215018528PS1-23-4085
09348215018511PS1-23-4083
09348215018504PS1-23-4081
09348215018498PS1-23-3167
09348215018481PS1-23-3165
09348215018474PS1-23-3163
09348215018467PS1-23-3161
09348215018450PS1-23-3127
09348215018443PS1-23-3125
09348215018436PS1-23-3123
09348215018429PS1-23-3121
09348215018412PS1-23-3087
09348215018405PS1-23-3085
09348215018399PS1-23-3083
09348215018382PS1-23-3081
09348215018375PS1-23-2167
09348215018368PS1-23-2165
09348215018351PS1-23-2163
09348215018344PS1-23-2161
09348215018337PS1-23-2127
09348215018320PS1-23-2125
09348215018313PS1-23-2123
09348215018306PS1-23-2121
09348215018290PS1-23-2087
09348215018283PS1-23-2085
09348215018276PS1-23-2083
09348215018269PS1-23-2081
09348215018252PS1-23-1167
09348215018245PS1-23-1165

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