Rx Knee PS Cemented Symmetrical Femur

GUDID 09348215122935

SIGNATURE ORTHOPAEDICS PTY LTD

Temporary knee prosthesis, non-customized

• Primary Device ID: 09348215122935
• NIH Device Record Key: 6a125170-f1da-40ab-ac89-ea4f72d35b38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rx Knee PS Cemented Symmetrical Femur
• Version Model Number: 121-25-0308
• 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	09348215122935 [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 PS Cemented Symmetrical Femur]

• 09348215122942: 121-25-0309
• 09348215122935: 121-25-0308
• 09348215122928: 121-25-0307
• 09348215122911: 121-25-0306
• 09348215122904: 121-25-0305
• 09348215122898: 121-25-0304
• 09348215122881: 121-25-0303
• 09348215122874: 121-25-0302
• 09348215122867: 121-25-0301