World Knee PS TiN Femur Left

GUDID 09348215105648

SIGNATURE ORTHOPAEDICS PTY LTD

Coated knee femur prosthesis

• Primary Device ID: 09348215105648
• NIH Device Record Key: e7b06603-16a7-4334-8764-894731007f37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Knee PS TiN Femur Left
• Version Model Number: 121-20-4201
• 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	09348215105648 [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 Left ]

• 09348215106065: 121-20-4901
• 09348215106003: 121-20-4801
• 09348215105945: 121-20-4701
• 09348215105884: 121-20-4601
• 09348215105822: 121-20-4501
• 09348215105761: 121-20-4401
• 09348215105709: 121-20-4301
• 09348215105648: 121-20-4201
• 09348215105587: 121-20-4101