TiN Coated Glenosphere

GUDID 03701037309568

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

FX SOLUTIONS

Shoulder glenoid fossa prosthesis, prefabricated

• Primary Device ID: 03701037309568
• NIH Device Record Key: a278c8cb-cf56-4c7d-b4f7-b08edfb8a22c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TiN Coated Glenosphere
• Version Model Number: 115-3211
• 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	03701037309568 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191146

FDA Product Code

• KWT: Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

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 [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