32mm Glenosphere and Humeral Cup

GUDID 03701037309377

HUMERAL CUP STANDARD PE/TA6V Ø32/+9

FX SOLUTIONS

Polyethylene reverse shoulder prosthesis cup

• Primary Device ID: 03701037309377
• NIH Device Record Key: 55358d83-3511-456a-8cdc-886fb3a96597
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 32mm Glenosphere and Humeral Cup
• Version Model Number: 102-0809
• Company DUNS: 263076196
• Company Name: FX SOLUTIONS
• 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: false
• 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	03701037309377 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192206

FDA Product Code

• PHX: Shoulder Prosthesis, Reverse Configuration

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: 2024-01-30
• Device Publish Date: 2024-01-22

On-Brand Devices [32mm Glenosphere and Humeral Cup]

• 03701037309377: HUMERAL CUP STANDARD PE/TA6V Ø32/+9
• 03701037309360: HUMERAL CUP STANDARD PE/TA6V Ø32/+6
• 03701037309353: HUMERAL CUP STANDARD PE/TA6V Ø32/+3