Origin DAA Stem, Coxa Vara

GUDID 09348215092801

SIGNATURE ORTHOPAEDICS PTY LTD

Coated femoral stem prosthesis, modular

• Primary Device ID: 09348215092801
• NIH Device Record Key: 76a5454e-a4dc-4950-8eae-16fb6c0b0f33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Origin DAA Stem, Coxa Vara
• Version Model Number: 111-39-1504
• 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	09348215092801 [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: 2022-08-29
• Device Publish Date: 2022-08-19

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

• 09348215092825: 111-39-1804
• 09348215092818: 111-39-1604
• 09348215092801: 111-39-1504
• 09348215092795: 111-39-1404
• 09348215092788: 111-39-1304
• 09348215092771: 111-39-1204
• 09348215092764: 111-39-1104
• 09348215092757: 111-39-1004
• 09348215092740: 111-39-0904