Genius Tibial Trial Monobloc PS - 13mm

GUDID 09348215072407

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215072407
• NIH Device Record Key: 1b50dd56-b96b-40d1-9c36-867894d5fec9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genius Tibial Trial Monobloc PS - 13mm
• Version Model Number: 122-10-0913
• 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: true
• 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	09348215072407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170613

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

[09348215072407]

Moist Heat or Steam Sterilization

[09348215072407]

Moist Heat or Steam Sterilization

[09348215072407]

Moist Heat or Steam Sterilization

[09348215072407]

Moist Heat or Steam Sterilization

[09348215072407]

Moist Heat or Steam Sterilization

[09348215072407]

Moist Heat or Steam Sterilization

[09348215072407]

Moist Heat or Steam Sterilization

[09348215072407]

Moist Heat or Steam Sterilization

[09348215072407]

Moist Heat or Steam Sterilization

[09348215072407]

Moist Heat or Steam Sterilization

[09348215072407]

Moist Heat or Steam Sterilization

[09348215072407]

Moist Heat or Steam Sterilization

[09348215072407]

Moist Heat or Steam Sterilization

[09348215072407]

Moist Heat or Steam Sterilization

[09348215072407]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-28
• Device Publish Date: 2020-08-20

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

• 09348215152673 - Proximal Reamer Ø12: 2025-10-07
• 09348215152680 - Proximal Reamer Ø13: 2025-10-07
• 09348215148898 - Rx Knee Femoral Box Cut Guide Size 1 - 2: 2025-09-04
• 09348215148904 - Rx Knee Femoral Box Cut Guide Size 3 - 4: 2025-09-04
• 09348215148911 - Rx Knee Femoral Box Cut Guide Size 5- 6: 2025-09-04
• 09348215148928 - Rx Knee Femoral Box Cut Guide Size 7 - 8: 2025-09-04
• 09348215148935 - Rx Knee Femoral Box Cut Guide Size 9 - 9: 2025-09-04
• 09348215117658 - Patella Sizer: 2025-09-03