Origin Hip Stem, Coxa Vara

GUDID 09348215051891

SIGNATURE ORTHOPAEDICS PTY LTD

Coated femoral stem prosthesis, modular

• Primary Device ID: 09348215051891
• NIH Device Record Key: de068473-e163-44e3-b505-4857d8e03456
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Origin Hip Stem, Coxa Vara
• Version Model Number: D111-18-1504
• 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	09348215051891 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161155

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: 2022-09-28
• Device Publish Date: 2022-09-20

On-Brand Devices [Origin Hip Stem, Coxa Vara]

• 09348215051914: D111-18-1804
• 09348215051907: D111-18-1604
• 09348215051891: D111-18-1504
• 09348215051884: D111-18-1404
• 09348215051877: D111-18-1304
• 09348215051860: D111-18-1204
• 09348215051853: D111-18-1104
• 09348215051846: D111-18-1004
• 09348215051839: D111-18-0904