Everglade Stem, High Offset

GUDID 09348215107291

SIGNATURE ORTHOPAEDICS PTY LTD

Coated hip femur prosthesis, modular

• Primary Device ID: 09348215107291
• NIH Device Record Key: b80ed8d1-e669-45a9-9b12-91a4d4563685
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Everglade Stem, High Offset
• Version Model Number: 111-45-1112
• 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	09348215107291 [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, High Offset]

• 09348215107307: 111-45-1212
• 09348215107291: 111-45-1112
• 09348215107284: 111-45-1012
• 09348215107277: 111-45-0912
• 09348215107260: 111-45-0812
• 09348215107253: 111-45-0712
• 09348215107246: 111-45-0612
• 09348215107239: 111-45-0512
• 09348215107222: 111-45-0412
• 09348215107215: 111-45-0312
• 09348215107208: 111-45-0212
• 09348215107192: 111-45-0112
• 09348215107185: 111-45-0012