Humelock II

GUDID 03701037311813

BONE GRAFT CUTTER

FX SOLUTIONS

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03701037311813
• NIH Device Record Key: 85a262c8-1507-42d5-b3c8-d0ab477c783f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Humelock II
• Version Model Number: 926-1045
• 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	03701037311813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140071

FDA Product Code

• HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Sterilization

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

[03701037311813]

Moist Heat or Steam Sterilization

[03701037311813]

Moist Heat or Steam Sterilization

[03701037311813]

Moist Heat or Steam Sterilization

[03701037311813]

Moist Heat or Steam Sterilization

[03701037311813]

Moist Heat or Steam Sterilization

[03701037311813]

Moist Heat or Steam Sterilization

[03701037311813]

Moist Heat or Steam Sterilization

[03701037311813]

Moist Heat or Steam Sterilization

[03701037311813]

Moist Heat or Steam Sterilization

[03701037311813]

Moist Heat or Steam Sterilization

[03701037311813]

Moist Heat or Steam Sterilization

[03701037311813]

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 [Humelock II]

• 03701037320532: HUMELOCK II TRAY
• 03701037311813: BONE GRAFT CUTTER
• 03701037311806: BONE GRAFT CUTTER
• 03701037311790: BONE GRAFT CUTTER
• 03701037311783: BONE GRAFT CUTTER
• 03701037311776: BONE GRAFT CUTTER