FX V135 Shoulder Prothesis

GUDID 03701037320464

AXIS WITH ALLEN BALL

FX SOLUTIONS

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03701037320464
• NIH Device Record Key: 8d10e701-eee1-4064-8bb8-e819ee3f7c22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FX V135 Shoulder Prothesis
• Version Model Number: 951-0501
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	03701037320464 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213117

FDA Product Code

• PHX: Shoulder Prosthesis, Reverse Configuration

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[03701037320464]

Moist Heat or Steam Sterilization

[03701037320464]

Moist Heat or Steam Sterilization

[03701037320464]

Moist Heat or Steam Sterilization

[03701037320464]

Moist Heat or Steam Sterilization

[03701037320464]

Moist Heat or Steam Sterilization

[03701037320464]

Moist Heat or Steam Sterilization

[03701037320464]

Moist Heat or Steam Sterilization

[03701037320464]

Moist Heat or Steam Sterilization

[03701037320464]

Moist Heat or Steam Sterilization

[03701037320464]

Moist Heat or Steam Sterilization

[03701037320464]

Moist Heat or Steam Sterilization

[03701037320464]

Moist Heat or Steam Sterilization

[03701037320464]

Moist Heat or Steam Sterilization

[03701037320464]

Moist Heat or Steam Sterilization

[03701037320464]

Moist Heat or Steam Sterilization

[03701037320464]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-10
• Device Publish Date: 2024-07-02

On-Brand Devices [FX V135 Shoulder Prothesis]

• 03701037320495: 15° BEVELED EXTREMITY
• 03701037320488: 7,5° BEVELED EXTREMITY
• 03701037320471: STRAIGHT TUBE
• 03701037320464: AXIS WITH ALLEN BALL
• 03701037320457: GLENOID REAMER Ø24 Hex 6