FX V135

GUDID 03701037316450

STABILITY TRIAL CUP 135-145° FOR IMPLANT Ø36 +3

FX SOLUTIONS

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03701037316450
• NIH Device Record Key: 9eaf8cbd-d159-45b2-a3b5-64aaef9f2541
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FX V135
• Version Model Number: 951-8903
• 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: 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	03701037316450 [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

[03701037316450]

Moist Heat or Steam Sterilization

[03701037316450]

Moist Heat or Steam Sterilization

[03701037316450]

Moist Heat or Steam Sterilization

[03701037316450]

Moist Heat or Steam Sterilization

[03701037316450]

Moist Heat or Steam Sterilization

[03701037316450]

Moist Heat or Steam Sterilization

[03701037316450]

Moist Heat or Steam Sterilization

[03701037316450]

Moist Heat or Steam Sterilization

[03701037316450]

Moist Heat or Steam Sterilization

[03701037316450]

Moist Heat or Steam Sterilization

[03701037316450]

Moist Heat or Steam Sterilization

[03701037316450]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-11
• Device Publish Date: 2025-08-01

On-Brand Devices [FX V135]

• 03701037321102: M GLENOID K-WIRE GUIDE +TEMPLATE W/10° ANTERIOR TILT
• 03701037321096: M GLENOID K-WIRE GUIDE +TEMPLATE W/5° ANTERIOR TILT
• 03701037321089: 911-2113
• 03701037321072: XS GLENOID K-WIRE GUIDE +TEMPLATE W/10° POSTERIOR TILT
• 03701037321065: M GLENOID K-WIRE GUIDE +TEMPLATE W/5° POSTERIOR TILT
• 03701037321058: XS GLENOID K-WIRE GUIDE +TEMPLATE W/5° POSTERIOR TILT
• 03701037321041: M GLENOID K-WIRE GUIDE +TEMPLATE W/10° SUPERIOR TILT
• 03701037321034: XS GLENOID K-WIRE GUIDE +TEMPLATE W/10° SUPERIOR TILT
• 03701037321027: M GLENOID K-WIRE GUIDE +TEMPLATE W/5° SUPERIOR TILT
• 03701037321010: XS GLENOID K-WIRE GUIDE +TEMPLATE W/5° SUPERIOR TILT
• 03701037316450: STABILITY TRIAL CUP 135-145° FOR IMPLANT Ø36 +3