World Knee CR All Poly Tibia

GUDID 09348215116323

SIGNATURE ORTHOPAEDICS PTY LTD

Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene

• Primary Device ID: 09348215116323
• NIH Device Record Key: c18a927a-6186-4ccc-90d5-e4147ce8aa77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Knee CR All Poly Tibia
• Version Model Number: 121-20-6819
• 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	09348215116323 [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: 2023-08-07
• Device Publish Date: 2023-07-28

On-Brand Devices [World Knee CR All Poly Tibia]

• 09348215116255: 121-20-6119
• 09348215116330: 121-20-6919
• 09348215116323: 121-20-6819
• 09348215116316: 121-20-6719
• 09348215116309: 121-20-6619
• 09348215116293: 121-20-6519
• 09348215116286: 121-20-6419
• 09348215116279: 121-20-6319
• 09348215116262: 121-20-6219
• 09348215116064: 121-20-6918
• 09348215116057: 121-20-6818
• 09348215116040: 121-20-6718
• 09348215116033: 121-20-6618
• 09348215116026: 121-20-6518
• 09348215116019: 121-20-6418
• 09348215116002: 121-20-6318
• 09348215115999: 121-20-6128
• 09348215115982: 121-20-6118