40mm Tib Drill

GUDID 09348215124977

SIGNATURE ORTHOPAEDICS PTY LTD

Fluted surgical drill bit, reusable

• Primary Device ID: 09348215124977
• NIH Device Record Key: 58a85b44-cd3c-40d0-84f2-8c1769833e10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 40mm Tib Drill
• Version Model Number: 122-22-0904
• 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	09348215124977 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222380

FDA Product Code

• HTW: Bit, Drill

Sterilization

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

[09348215124977]

Moist Heat or Steam Sterilization

[09348215124977]

Moist Heat or Steam Sterilization

[09348215124977]

Moist Heat or Steam Sterilization

[09348215124977]

Moist Heat or Steam Sterilization

[09348215124977]

Moist Heat or Steam Sterilization

[09348215124977]

Moist Heat or Steam Sterilization

[09348215124977]

Moist Heat or Steam Sterilization

[09348215124977]

Moist Heat or Steam Sterilization

[09348215124977]

Moist Heat or Steam Sterilization

[09348215124977]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-12
• Device Publish Date: 2025-03-04

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

• 09348215124977 - 40mm Tib Drill: 2025-03-12
• 09348215124977 - 40mm Tib Drill: 2025-03-12
• 09348215124984 - 80mm Tib Drill: 2025-03-12
• 09348215125424 - V2 TRIVERSE TIBIAL TRAY PI: 2025-03-12
• 09348215127497 - V2 TRIVERSE TIBIAL TOWER: 2025-03-12
• 09348215127541 - V2 TRIVERSE PS BOX CUTTING JIG INSERT: 2025-03-12
• 09348215127572 - Patella Drill: 2025-03-12
• 09348215127589 - Femoral Lug Drill: 2025-03-12
• 09348215127619 - V2 TRIVERSE IMPACTOR FEMORAL: 2025-03-12