Everglade Stem, Standard Offset

GUDID 09348215107147

SIGNATURE ORTHOPAEDICS PTY LTD

Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular

• Primary Device ID: 09348215107147
• NIH Device Record Key: 304da5cb-4d96-402e-b04d-0d8db9e953ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Everglade Stem, Standard Offset
• Version Model Number: 111-45-0911
• 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	09348215107147 [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, Standard Offset]

• 09348215107178: 111-45-1211
• 09348215107161: 111-45-1111
• 09348215107154: 111-45-1011
• 09348215107147: 111-45-0911
• 09348215107130: 111-45-0811
• 09348215107123: 111-45-0711
• 09348215107116: 111-45-0611
• 09348215107109: 111-45-0511
• 09348215107093: 111-45-0411
• 09348215107086: 111-45-0311
• 09348215107079: 111-45-0211
• 09348215107062: 111-45-0111
• 09348215107055: 111-45-0011