Humelock Reversed System 105-3211

GUDID 03701037309483

HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW CoCr/TA6V 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 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 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: 03701037309483
• NIH Device Record Key: 8a1daf58-5b19-4767-b2e8-b09bdbf9ceb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Humelock Reversed System
• Version Model Number: 105-3211
• Catalog Number: 105-3211
• 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: false
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701037309483 [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: 2024-03-05
• Device Publish Date: 2024-02-26

On-Brand Devices [Humelock Reversed System]

• 03701037309483: HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW CoCr/TA6V 10° TILT Ø32mm
• 03701037309476: HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW CoCr/TA6V 10° TILT Ø32mm