Aurora Anterior Lumbar Plate Screw

GUDID 09348215125554

SIGNATURE ORTHOPAEDICS PTY LTD

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 09348215125554
• NIH Device Record Key: b9faee56-ffed-47f2-a2ef-d69d1410e92b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aurora Anterior Lumbar Plate Screw
• Version Model Number: 131-05-1528
• 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	09348215125554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163625

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

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: 2024-02-12
• Device Publish Date: 2024-02-02

On-Brand Devices [Aurora Anterior Lumbar Plate Screw]

• 09348215125615: 131-05-1828
• 09348215125608: 131-05-1824
• 09348215125592: 131-05-1728
• 09348215125585: 131-05-1724
• 09348215125578: 131-05-1628
• 09348215125561: 131-05-1624
• 09348215125554: 131-05-1528
• 09348215125547: 131-05-1524