Rx Knee CR Cemented Symmetrical Femur

GUDID 09348215123017

SIGNATURE ORTHOPAEDICS PTY LTD

Temporary knee prosthesis, non-customized

• Primary Device ID: 09348215123017
• NIH Device Record Key: 88529479-de0a-492f-a74d-d63a189901bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rx Knee CR Cemented Symmetrical Femur
• Version Model Number: 121-25-0317
• 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	09348215123017 [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: 2024-11-20
• Device Publish Date: 2024-11-12

On-Brand Devices [Rx Knee CR Cemented Symmetrical Femur]

• 09348215123031: 121-25-0319
• 09348215123024: 121-25-0318
• 09348215123017: 121-25-0317
• 09348215123000: 121-25-0316
• 09348215122997: 121-25-0315
• 09348215122980: 121-25-0314
• 09348215122973: 121-25-0313
• 09348215122966: 121-25-0312
• 09348215122959: 121-25-0311