World Knee Asymmetrical Patella Vit-E

GUDID 09348215134389

SIGNATURE ORTHOPAEDICS PTY LTD

Polyethylene patella prosthesis

• Primary Device ID: 09348215134389
• NIH Device Record Key: e9e167e9-b9af-4f77-9d05-f99edd82261e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Knee Asymmetrical Patella Vit-E
• Version Model Number: 121-20-8610E
• 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	09348215134389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181530

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: 2024-10-16
• Device Publish Date: 2024-10-08

On-Brand Devices [World Knee Asymmetrical Patella Vit-E ]

• 09348215134389: 121-20-8610E
• 09348215134372: 121-20-8510E
• 09348215134365: 121-20-8410E
• 09348215134358: 121-20-8210E
• 09348215134341: 121-20-8010E