World Knee Spherical Patella – Finned Peg Vit-E

GUDID 09348215134259

SIGNATURE ORTHOPAEDICS PTY LTD

Polyethylene patella prosthesis

• Primary Device ID: 09348215134259
• NIH Device Record Key: 084f3ec3-f9c7-4572-ae79-42f3a9eccb10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Knee Spherical Patella – Finned Peg Vit-E
• Version Model Number: 121-20-8120E
• 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	09348215134259 [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 Spherical Patella – Finned Peg Vit-E ]

• 09348215134242: 121-20-8921E
• 09348215134235: 121-20-8020E
• 09348215134334: 121-20-8620E
• 09348215134327: 121-20-8520E
• 09348215134310: 121-20-8924E
• 09348215134303: 121-20-8420E
• 09348215134297: 121-20-8923E
• 09348215134280: 121-20-8320E
• 09348215134273: 121-20-8220E
• 09348215134266: 121-20-8922E
• 09348215134259: 121-20-8120E