TiN Coated Glenosphere 115-3210

GUDID 03701037309551

HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW COCR/TA6V/TiN 10° TILT Ø32mm

FX SOLUTIONS

Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated

• Primary Device ID: 03701037309551
• NIH Device Record Key: 89abef2c-2aa8-4892-b7cf-03f832342abe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TiN Coated Glenosphere
• Version Model Number: 115-3210
• Catalog Number: 115-3210
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701037309551 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191146

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: 2024-01-11
• Device Publish Date: 2024-01-03

On-Brand Devices [TiN Coated Glenosphere]

• 03701037309551: HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW COCR/TA6V/TiN 10° TILT Ø32mm
• 03701037309568: HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW COCR/TA6V/TiN 10° TILT Ø32mm