World Neutral Liner Size 32C

GUDID 09348215065195

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215065195
• NIH Device Record Key: 5e0af356-e0b9-43f3-a704-d9b104f677ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Neutral Liner Size 32C
• Version Model Number: 111-49-2054
• 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	09348215065195 [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

• 09348215124977 - 40mm Tib Drill: 2025-03-12
• 09348215124984 - 80mm Tib Drill: 2025-03-12
• 09348215125424 - V2 TRIVERSE TIBIAL TRAY PI: 2025-03-12
• 09348215127497 - V2 TRIVERSE TIBIAL TOWER: 2025-03-12
• 09348215127541 - V2 TRIVERSE PS BOX CUTTING JIG INSERT: 2025-03-12
• 09348215127572 - Patella Drill: 2025-03-12
• 09348215127589 - Femoral Lug Drill: 2025-03-12
• 09348215127619 - V2 TRIVERSE IMPACTOR FEMORAL: 2025-03-12