World Knee CR TiN Femur Symmetric

GUDID 09348215105631

SIGNATURE ORTHOPAEDICS PTY LTD

Coated knee femur prosthesis

• Primary Device ID: 09348215105631
• NIH Device Record Key: aa225c4a-5500-40f0-8dcb-c3b9abe16b6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Knee CR TiN Femur Symmetric
• Version Model Number: 121-20-4113
• 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	09348215105631 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223062

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: 2023-03-08
• Device Publish Date: 2023-02-28

On-Brand Devices [World Knee CR TiN Femur Symmetric]

• 09348215106119: 121-20-4913
• 09348215106058: 121-20-4813
• 09348215105990: 121-20-4713
• 09348215105938: 121-20-4613
• 09348215105877: 121-20-4513
• 09348215105815: 121-20-4413
• 09348215105754: 121-20-4313
• 09348215105693: 121-20-4213
• 09348215105631: 121-20-4113