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

• 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