Brisbane ALIF Cage

GUDID 09348215018320

SIGNATURE ORTHOPAEDICS PTY LTD

Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 09348215018320
• NIH Device Record Key: bd6f5604-26d7-41c0-a730-174878c18f7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brisbane ALIF Cage
• Version Model Number: PS1-23-2125
• Company DUNS: 751993028
• Company Name: SIGNATURE ORTHOPAEDICS PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09348215018320 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172019

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-24
• Device Publish Date: 2018-01-10

On-Brand Devices [Brisbane ALIF Cage]

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