Rx Knee All Poly Half Augment – UHMWPE - 8mm Size 3

GUDID 09348215146627

SIGNATURE ORTHOPAEDICS PTY LTD

Temporary knee prosthesis, non-customized

• Primary Device ID: 09348215146627
• NIH Device Record Key: 0e5b7926-0cc2-4d2a-9f75-d03c96fd9c6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rx Knee All Poly Half Augment – UHMWPE - 8mm Size 3
• Version Model Number: 121-20-9343
• 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	09348215146627 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240683

FDA Product Code

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

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: 2025-03-27
• Device Publish Date: 2025-03-19

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

• 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
• 09348215125417 - V2 TRIVERSE LOCKING BAR PI: 2025-04-17
• 09348215125431 - V2 TRIVERSE FEMORAL NOTCH REAMER: 2025-04-17