Rx Knee All Poly Full, 4° Draft Augment - UHMWPE - 12mm Size 2

GUDID 09348215110437

SIGNATURE ORTHOPAEDICS PTY LTD

Temporary knee prosthesis, non-customized

• Primary Device ID: 09348215110437
• NIH Device Record Key: 36ed6622-f943-47d4-80ba-f7da363cd546
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rx Knee All Poly Full, 4° Draft Augment - UHMWPE - 12mm Size 2
• Version Model Number: 121-20-9182
• 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	09348215110437 [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

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