FX V135

GUDID 00840452402478

STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø36+6

FX Shoulder Solutions, Inc.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00840452402478
• NIH Device Record Key: d9c03682-7e58-4985-96f0-f6cf58ff99b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FX V135
• Version Model Number: 950-2806
• Company DUNS: 115052068
• Company Name: FX Shoulder Solutions, Inc.
• 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: true
• Expiration Date: false
• 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	00840452402478 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223801

FDA Product Code

• PHX: Shoulder Prosthesis, Reverse Configuration

Sterilization

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

[00840452402478]

Moist Heat or Steam Sterilization

[00840452402478]

Moist Heat or Steam Sterilization

[00840452402478]

Moist Heat or Steam Sterilization

[00840452402478]

Moist Heat or Steam Sterilization

[00840452402478]

Moist Heat or Steam Sterilization

[00840452402478]

Moist Heat or Steam Sterilization

[00840452402478]

Moist Heat or Steam Sterilization

[00840452402478]

Moist Heat or Steam Sterilization

[00840452402478]

Moist Heat or Steam Sterilization

[00840452402478]

Moist Heat or Steam Sterilization

[00840452402478]

Moist Heat or Steam Sterilization

[00840452402478]

Moist Heat or Steam Sterilization

[00840452402478]

Moist Heat or Steam Sterilization

[00840452402478]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-04
• Device Publish Date: 2025-07-25

On-Brand Devices [FX V135]

• 00840452402492: STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø36+12
• 00840452402478: STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø36+6
• 00840452402461: STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø36+3
• 00840452402454: STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø32+18
• 00840452402447: STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø32+15
• 00840452402430: 950-1812
• 00840452402423: STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø32+9
• 00840452402416: STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø32+6
• 00840452402409: STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø32+3