World Knee PS TiN Femur Right

GUDID 09348215105716

SIGNATURE ORTHOPAEDICS PTY LTD

Coated knee femur prosthesis

• Primary Device ID: 09348215105716
• NIH Device Record Key: 71814c25-6b6f-4c96-b710-0d73fbf94bad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Knee PS TiN Femur Right
• Version Model Number: 121-20-4302
• 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	09348215105716 [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 Right]

• 09348215106072: 121-20-4902
• 09348215106010: 121-20-4802
• 09348215105952: 121-20-4702
• 09348215105891: 121-20-4602
• 09348215105839: 121-20-4502
• 09348215105778: 121-20-4402
• 09348215105716: 121-20-4302
• 09348215105655: 121-20-4202
• 09348215105594: 121-20-4102