Rx Knee All Poly Full, 4° Draft Augment - UHMWPE - 12mm Size 5

GUDID 09348215110468

SIGNATURE ORTHOPAEDICS PTY LTD

Temporary knee prosthesis, non-customized

• Primary Device ID: 09348215110468
• NIH Device Record Key: 1fb81fef-c8b9-46a1-ad7d-f85bf207511d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rx Knee All Poly Full, 4° Draft Augment - UHMWPE - 12mm Size 5
• Version Model Number: 121-20-9185
• 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	09348215110468 [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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• 09348215134525 - Nebula Standard Offset Size 1: 2025-03-28
• 09348215134532 - Nebula Standard Offset Size 2: 2025-03-28
• 09348215134549 - Nebula Standard Offset Size 3: 2025-03-28
• 09348215134556 - Nebula Standard Offset Size 4: 2025-03-28
• 09348215134563 - Nebula Standard Offset Size 5: 2025-03-28