Rx Knee Spherical Patella

GUDID 09348215123765

SIGNATURE ORTHOPAEDICS PTY LTD

Temporary knee prosthesis, non-customized

• Primary Device ID: 09348215123765
• NIH Device Record Key: f6c1b765-17a3-41e0-b437-d8547b6c98d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rx Knee Spherical Patella
• Version Model Number: 121-25-8400
• 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	09348215123765 [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 Spherical Patella]

• 09348215123796: 121-25-8600
• 09348215123789: 121-25-8500
• 09348215123772: 121-25-8904
• 09348215123765: 121-25-8400
• 09348215123758: 121-25-8903
• 09348215123741: 121-25-8300
• 09348215123734: 121-25-8200
• 09348215123727: 121-25-8902
• 09348215123710: 121-25-8100
• 09348215123703: 121-25-8901
• 09348215123697: 121-25-8000