Spherical Patella Trial Size Ø31x9mm

GUDID 09348215139490

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215139490
• NIH Device Record Key: 70fc3305-48d5-42a8-ba65-64807156c5c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spherical Patella Trial Size Ø31x9mm
• Version Model Number: 122-18-0493
• 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	09348215139490 [Primary]

FDA Product Code

• HWT: Template

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: 2025-09-03
• Device Publish Date: 2025-08-26

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

• 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
• 09348215117665 - Ligament Balancing Block Size 10-12: 2025-09-03
• 09348215117672 - Ligament Balancing Block Size 14-16: 2025-09-03