Signasure World Insert

GUDID 09348215122720

SIGNATURE ORTHOPAEDICS PTY LTD

Metallic acetabular liner

• Primary Device ID: 09348215122720
• NIH Device Record Key: 75c5fd3c-13bd-49a5-8a15-4909259a9de0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Signasure World Insert
• Version Model Number: 111-27-0748
• 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	09348215122720 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220495

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

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: 2025-03-28
• Device Publish Date: 2025-03-20

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

• 09348215134938 - Distal Centraliser Narrow: 2025-05-13
• 09348215134945 - Distal Centraliser Wide: 2025-05-13
• 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