Verteloc Lordotic Lumbar Cage

GUDID 09348215129507

SIGNATURE ORTHOPAEDICS PTY LTD

Metallic spinal interbody fusion cage

• Primary Device ID: 09348215129507
• NIH Device Record Key: 928e5e67-bc8c-4174-b602-6301f2b28eee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Verteloc Lordotic Lumbar Cage
• Version Model Number: 131-035-929
• 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	09348215129507 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172020

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, 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: 2024-03-20
• Device Publish Date: 2024-03-12

On-Brand Devices [Verteloc Lordotic Lumbar Cage ]

• 09348215129507: 131-035-929
• 09348215129491: 131-035-729
• 09348215129484: 131-035-529
• 09348215129477: 131-035-329
• 09348215129460: 131-035-129
• 09348215129453: 131-030-929
• 09348215129446: 131-030-729
• 09348215129439: 131-030-529
• 09348215129422: 131-030-329
• 09348215129415: 131-030-129