World Cup Size 64mm

GUDID 09348215065133

SIGNATURE ORTHOPAEDICS PTY LTD

Acetabular shell

• Primary Device ID: 09348215065133
• NIH Device Record Key: 428a2ee0-a714-4d48-b327-9267580195fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Cup Size 64mm
• Version Model Number: 111-49-5064
• 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	09348215065133 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201278

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

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: 2021-03-15
• Device Publish Date: 2021-03-07

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

• 09348215129538 - TriVerse Asymmetric Patella: 2025-02-19
• 09348215092832 - Origin Complete Lateral Offset Collarless Cementless: 2025-01-01
• 09348215092849 - Origin Complete Lateral Offset Collarless Cementless: 2025-01-01
• 09348215092856 - Origin Complete Lateral Offset Collarless Cementless: 2025-01-01
• 09348215092863 - Origin Complete Lateral Offset Collarless Cementless: 2025-01-01
• 09348215092870 - Origin Complete Lateral Offset Collarless Cementless: 2025-01-01
• 09348215092887 - Origin Complete Lateral Offset Collarless Cementless: 2025-01-01
• 09348215092894 - Origin Complete Lateral Offset Collarless Cementless: 2025-01-01