World Knee Spherical Patella – Finned Peg

GUDID 09348215139193

SIGNATURE ORTHOPAEDICS PTY LTD

Polyethylene patella prosthesis

• Primary Device ID: 09348215139193
• NIH Device Record Key: 4061aa74-b8f7-472c-b3d2-5025a856d7a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Knee Spherical Patella – Finned Peg
• Version Model Number: 121-20-8620
• 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	09348215139193 [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 – Finned Peg]

• 09348215139230: 121-20-8924
• 09348215139223: 121-20-8923
• 09348215139216: 121-20-8922
• 09348215139209: 121-20-8921
• 09348215139193: 121-20-8620
• 09348215139186: 121-20-8520
• 09348215139179: 121-20-8420
• 09348215139162: 121-20-8320
• 09348215139155: 121-20-8220
• 09348215139148: 121-20-8120
• 09348215139131: 121-20-8020