TriVerse AS Tibia Insert Trial, 87-91x16

GUDID 09348215132675

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215132675
• NIH Device Record Key: 87f34fcc-f912-4a5c-9e27-3481a543e329
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriVerse AS Tibia Insert Trial, 87-91x16
• Version Model Number: 122-22-6876
• 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	09348215132675 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222380

FDA Product Code

• HWT: Template

Sterilization

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

[09348215132675]

Moist Heat or Steam Sterilization

[09348215132675]

Moist Heat or Steam Sterilization

[09348215132675]

Moist Heat or Steam Sterilization

[09348215132675]

Moist Heat or Steam Sterilization

[09348215132675]

Moist Heat or Steam Sterilization

[09348215132675]

Moist Heat or Steam Sterilization

[09348215132675]

Moist Heat or Steam Sterilization

[09348215132675]

Moist Heat or Steam Sterilization

[09348215132675]

Moist Heat or Steam Sterilization

[09348215132675]

Moist Heat or Steam Sterilization

[09348215132675]

Moist Heat or Steam Sterilization

[09348215132675]

Moist Heat or Steam Sterilization

[09348215132675]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-17
• Device Publish Date: 2025-04-09

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

• 09348215124960 - Tib Canal Reamer Bushing: 2025-04-17
• 09348215124991 - V2 TRVRSE ASYMM PATELLA TRIAL SIZE_28X6.2: 2025-04-17
• 09348215125004 - V2 TRIVERSE ASYMM PATELLA TRIAL SZ 31X6.2: 2025-04-17
• 09348215125011 - V2 TRIVERSE ASYMM PATELLA TRIAL SZ 31X8: 2025-04-17
• 09348215125028 - V2 TRIVERSE ASYMM PATELLA TRIAL SZ 34X8.5: 2025-04-17
• 09348215125035 - V2 TRIVERSE ASYMM PATELLA TRIAL SZ 37X10: 2025-04-17
• 09348215125417 - V2 TRIVERSE LOCKING BAR PI: 2025-04-17
• 09348215125431 - V2 TRIVERSE FEMORAL NOTCH REAMER: 2025-04-17