Australis ALIF Cage

GUDID 09348215127909

SIGNATURE ORTHOPAEDICS PTY LTD

Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 09348215127909
• NIH Device Record Key: 58ce7762-a48b-4095-893a-11da96c7d324
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Australis ALIF Cage
• Version Model Number: 131-07-1402
• 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	09348215127909 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-20
• Device Publish Date: 2024-02-12

On-Brand Devices [Australis ALIF Cage]

• 09348215128043: 131-07-2023
• 09348215128036: 131-07-1823
• 09348215128029: 131-07-1623
• 09348215128012: 131-07-2022
• 09348215128005: 131-07-1822
• 09348215127992: 131-07-1622
• 09348215127985: 131-07-1821
• 09348215127978: 131-07-1621
• 09348215127961: 131-07-1803
• 09348215127954: 131-07-1603
• 09348215127947: 131-07-1403
• 09348215127930: 131-07-1203
• 09348215127923: 131-07-1802
• 09348215127916: 131-07-1602
• 09348215127909: 131-07-1402
• 09348215127893: 131-07-1202
• 09348215127886: 131-07-1801
• 09348215127879: 131-07-1601
• 09348215127862: 131-07-1401
• 09348215127855: 131-07-1201
• 09348215127800: 131-07-2453
• 09348215127794: 131-07-2253
• 09348215127787: 131-07-2053
• 09348215127770: 131-07-2352
• 09348215127763: 131-07-2152
• 09348215127756: 131-07-1852
• 09348215127749: 131-07-2151
• 09348215127732: 131-07-1951
• 09348215127725: 131-07-1751
• 09348215127718: 131-07-1462
• 09348215127701: 131-07-1262
• 09348215127695: 131-07-1452
• 09348215127688: 131-07-1252