Full wedge baseplates

GUDID 03701037319512

GUIDE BROCHE TOTAL AUGMENTE 7,5

FX SOLUTIONS

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03701037319512
• NIH Device Record Key: 5c5c5e6f-4a71-4bc6-8bce-e0e2b0cb0047
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Full wedge baseplates
• Version Model Number: 951-0107
• 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	03701037319512 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240278

FDA Product Code

• PHX: Shoulder Prosthesis, Reverse Configuration

Sterilization

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

[03701037319512]

Moist Heat or Steam Sterilization

[03701037319512]

Moist Heat or Steam Sterilization

[03701037319512]

Moist Heat or Steam Sterilization

[03701037319512]

Moist Heat or Steam Sterilization

[03701037319512]

Moist Heat or Steam Sterilization

[03701037319512]

Moist Heat or Steam Sterilization

[03701037319512]

Moist Heat or Steam Sterilization

[03701037319512]

Moist Heat or Steam Sterilization

[03701037319512]

Moist Heat or Steam Sterilization

[03701037319512]

Moist Heat or Steam Sterilization

[03701037319512]

Moist Heat or Steam Sterilization

[03701037319512]

Moist Heat or Steam Sterilization

[03701037319512]

Moist Heat or Steam Sterilization

[03701037319512]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-23
• Device Publish Date: 2025-06-13

Devices Manufactured by FX SOLUTIONS

• 03701037311776 - Humelock II: 2025-08-11 BONE GRAFT CUTTER
• 03701037311783 - Humelock II: 2025-08-11 BONE GRAFT CUTTER
• 03701037311790 - Humelock II: 2025-08-11 BONE GRAFT CUTTER
• 03701037311806 - Humelock II: 2025-08-11 BONE GRAFT CUTTER
• 03701037311813 - Humelock II: 2025-08-11 BONE GRAFT CUTTER
• 03701037316450 - FX V135: 2025-08-11 STABILITY TRIAL CUP 135-145° FOR IMPLANT Ø36 +3
• 03701037321133 - Humelock Reversed: 2025-08-11 HOLE SAW Ø26mm H14mm WITH DRILL Ø8mm/HUDSON
• 03701037321140 - Humelock Reversed Shoulder: 2025-08-11 STARTER Ø06mm / HUDSON