Rx Knee Femoral Augment

GUDID 09348215123116

SIGNATURE ORTHOPAEDICS PTY LTD

Temporary knee prosthesis, non-customized

• Primary Device ID: 09348215123116
• NIH Device Record Key: efa181e3-e9f5-4a46-8413-1cec4cdd26f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rx Knee Femoral Augment
• Version Model Number: 121-25-0124
• 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	09348215123116 [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 Femoral Augment]

• 09348215123352: 121-25-0147
• 09348215123345: 121-25-0137
• 09348215123291: 121-25-0144
• 09348215123284: 121-25-0134
• 09348215123239: 121-25-0141
• 09348215123222: 121-25-0131
• 09348215123178: 121-25-0127
• 09348215123161: 121-25-0117
• 09348215123116: 121-25-0124
• 09348215123109: 121-25-0114
• 09348215123055: 121-25-0121
• 09348215123048: 121-25-0111