Origin 125° Short Neck Hip Stem

GUDID 09348215083557

SIGNATURE ORTHOPAEDICS PTY LTD

Coated femoral stem prosthesis, modular

• Primary Device ID: 09348215083557
• NIH Device Record Key: 717b7f9a-6f98-40bd-8594-394e9ad0d410
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Origin 125° Short Neck Hip Stem
• Version Model Number: 111-18-0825
• 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	09348215083557 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161155

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: 2022-03-16
• Device Publish Date: 2022-03-08

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

• 09348215135362 - World Cup Liner – Neutral Lateralised: 2024-12-11
• 09348215135379 - World Cup Liner – Neutral Lateralised: 2024-12-11
• 09348215135386 - World Cup Liner – Neutral Lateralised: 2024-12-11
• 09348215135393 - World Cup Liner – Neutral Lateralised: 2024-12-11
• 09348215135409 - World Cup Liner – Neutral Lateralised: 2024-12-11
• 09348215135416 - World Cup Liner – Neutral Lateralised: 2024-12-11
• 09348215135423 - World Cup Liner – Neutral Lateralised: 2024-12-11
• 09348215135430 - World Cup Liner – Neutral Lateralised: 2024-12-11