Rx Knee Tibial Stem

GUDID 09348215131630

SIGNATURE ORTHOPAEDICS PTY LTD

Temporary knee prosthesis, non-customized

• Primary Device ID: 09348215131630
• NIH Device Record Key: 94b1f110-3510-4684-8995-8fabd5ccaf8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rx Knee Tibial Stem
• Version Model Number: 121-20-9102
• 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	09348215131630 [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 Tibial Stem]

• 09348215131685: 121-20-9107
• 09348215131678: 121-20-9106
• 09348215131661: 121-20-9105
• 09348215131654: 121-20-9104
• 09348215131647: 121-20-9103
• 09348215131630: 121-20-9102
• 09348215131623: 121-20-9101
• 09348215131616: 121-20-9100