World Knee Spherical Patella Vit-E

GUDID 09348215134211

SIGNATURE ORTHOPAEDICS PTY LTD

Polyethylene patella prosthesis

• Primary Device ID: 09348215134211
• NIH Device Record Key: 2bacb630-237f-45d0-a244-7bd1dc951fc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Knee Spherical Patella Vit-E
• Version Model Number: 121-20-8500E
• 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	09348215134211 [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: 2024-10-14
• Device Publish Date: 2024-10-04

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

• 09348215134228: 121-20-8600E
• 09348215134211: 121-20-8500E
• 09348215134204: 121-20-8904E
• 09348215134198: 121-20-8400E
• 09348215134181: 121-20-8903E
• 09348215134174: 121-20-8300E
• 09348215134167: 121-20-8200E
• 09348215134150: 121-20-8902E
• 09348215134143: 121-20-8100E
• 09348215134136: 121-20-8901E
• 09348215134129: 121-20-8000E