Origin Complete Lateral Offset Collared Cementless

GUDID 09348215093020

SIGNATURE ORTHOPAEDICS PTY LTD

Coated femoral stem prosthesis, modular

• Primary Device ID: 09348215093020
• NIH Device Record Key: 30d2880b-10f1-46d4-84f6-8e777286c45e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Origin Complete Lateral Offset Collared Cementless
• Version Model Number: 111-53-1003
• 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	09348215093020 [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 Collared Cementless]

• 09348215093020: 111-53-1003
• 09348215093013: 111-53-0903
• 09348215093006: 111-53-0803
• 09348215092993: 111-53-0703
• 09348215092986: 111-53-0603
• 09348215092979: 111-53-0503
• 09348215092962: 111-53-0403
• 09348215092955: 111-53-0303
• 09348215092948: 111-53-0203
• 09348215092931: 111-53-0103