Origin TT Trial Neck High Offset

GUDID 09348215137847

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic broach

• Primary Device ID: 09348215137847
• NIH Device Record Key: a133bcde-0d91-4ac9-b698-d6fd968f5abf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Origin TT Trial Neck High Offset
• Version Model Number: 592-001
• 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	09348215137847 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243029

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[09348215137847]

Moist Heat or Steam Sterilization

[09348215137847]

Moist Heat or Steam Sterilization

[09348215137847]

Moist Heat or Steam Sterilization

[09348215137847]

Moist Heat or Steam Sterilization

[09348215137847]

Moist Heat or Steam Sterilization

[09348215137847]

Moist Heat or Steam Sterilization

[09348215137847]

Moist Heat or Steam Sterilization

[09348215137847]

Moist Heat or Steam Sterilization

[09348215137847]

Moist Heat or Steam Sterilization

[09348215137847]

Moist Heat or Steam Sterilization

[09348215137847]

Moist Heat or Steam Sterilization

[09348215137847]

Moist Heat or Steam Sterilization

[09348215137847]

Moist Heat or Steam Sterilization

[09348215137847]

Moist Heat or Steam Sterilization

[09348215137847]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-28
• Device Publish Date: 2025-03-20

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