Origin Complete Lateral Offset Collarless Cementless

GUDID 09348215092863

SIGNATURE ORTHOPAEDICS PTY LTD

Coated femoral stem prosthesis, modular

• Primary Device ID: 09348215092863
• NIH Device Record Key: f8f6f688-1a8c-4ccd-803d-d9b24f585f1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Origin Complete Lateral Offset Collarless Cementless
• Version Model Number: 111-53-0401
• 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	09348215092863 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121297

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-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: 2025-01-01
• Device Publish Date: 2024-12-24

On-Brand Devices [Origin Complete Lateral Offset Collarless Cementless]

• 09348215092924: 111-53-1001
• 09348215092917: 111-53-0901
• 09348215092900: 111-53-0801
• 09348215092894: 111-53-0701
• 09348215092887: 111-53-0601
• 09348215092870: 111-53-0501
• 09348215092863: 111-53-0401
• 09348215092856: 111-53-0301
• 09348215092849: 111-53-0201
• 09348215092832: 111-53-0101