World Knee PS TiN Femur Symmetric

GUDID 09348215105907

SIGNATURE ORTHOPAEDICS PTY LTD

Coated knee femur prosthesis

• Primary Device ID: 09348215105907
• NIH Device Record Key: f959ee9a-e455-446d-8cad-3365531d94b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Knee PS TiN Femur Symmetric
• Version Model Number: 121-20-4603
• 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	09348215105907 [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 PS TiN Femur Symmetric]

• 09348215106089: 121-20-4903
• 09348215106027: 121-20-4803
• 09348215105969: 121-20-4703
• 09348215105907: 121-20-4603
• 09348215105846: 121-20-4503
• 09348215105785: 121-20-4403
• 09348215105723: 121-20-4303
• 09348215105662: 121-20-4203
• 09348215105600: 121-20-4103