Origin Complete Standard Offset Collared Cementless

GUDID 09348215093167

SIGNATURE ORTHOPAEDICS PTY LTD

Coated femoral stem prosthesis, modular

• Primary Device ID: 09348215093167
• NIH Device Record Key: 77d19920-0668-4c43-9d70-582d4a01ef4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Origin Complete Standard Offset Collared Cementless
• Version Model Number: 111-53-0402
• 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	09348215093167 [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 Standard Offset Collared Cementless]

• 09348215093228: 111-53-1002
• 09348215093211: 111-53-0902
• 09348215093204: 111-53-0802
• 09348215093198: 111-53-0702
• 09348215093181: 111-53-0602
• 09348215093174: 111-53-0502
• 09348215093167: 111-53-0402
• 09348215093150: 111-53-0302
• 09348215093143: 111-53-0202
• 09348215093136: 111-53-0102