Trial Cage

GUDID 09348215043858

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215043858
• NIH Device Record Key: 9c9381f0-c192-432c-a878-2c6b753ad45b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trial Cage
• Version Model Number: 132-072-004
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	09348215043858 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172020

FDA Product Code

• HWT: Template
• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[09348215043858]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-07-01
• Device Publish Date: 2018-10-05

On-Brand Devices [Trial Cage]

• 09348215043902: 132-072-077
• 09348215043896: 132-072-012
• 09348215043889: 132-072-010
• 09348215043872: 132-072-008
• 09348215043865: 132-072-006
• 09348215043858: 132-072-004
• 09348215043841: 132-072-001