Everglade Stem, Ultra High Offset

GUDID 09348215107376

SIGNATURE ORTHOPAEDICS PTY LTD

Coated hip femur prosthesis, modular

• Primary Device ID: 09348215107376
• NIH Device Record Key: 59c3be09-4a1c-4aa4-8a7f-53253c6aa0a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Everglade Stem, Ultra High Offset
• Version Model Number: 111-45-1213
• 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	09348215107376 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211505

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 [Everglade Stem, Ultra High Offset]

• 09348215107437: 111-45-0513
• 09348215107376: 111-45-1213
• 09348215107369: 111-45-1113
• 09348215107352: 111-45-1013
• 09348215107345: 111-45-0913
• 09348215107338: 111-45-0813
• 09348215107321: 111-45-0713
• 09348215107314: 111-45-0613