FuzeFix Chamfered Screw

GUDID 00840124514706

Capital Fragment Guide Threaded

FUSION ORTHOPEDICS, LLC

Custom-made orthopaedic/craniofacial surgical guide

• Primary Device ID: 00840124514706
• NIH Device Record Key: a15f3725-1a0e-4a7c-816b-e054d10a9f91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FuzeFix Chamfered Screw
• Version Model Number: TN-CS-9025
• Company DUNS: 080307067
• Company Name: FUSION ORTHOPEDICS, LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• Donation Id Number: true
• 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	00840124514706 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170038

FDA Product Code

• PBF: Orthopaedic Surgical Planning And Instrument Guides

Sterilization

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

[00840124514706]

Moist Heat or Steam Sterilization

[00840124514706]

Moist Heat or Steam Sterilization

[00840124514706]

Moist Heat or Steam Sterilization

[00840124514706]

Moist Heat or Steam Sterilization

[00840124514706]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-23
• Device Publish Date: 2024-12-13

On-Brand Devices [FuzeFix Chamfered Screw]

• 00840124514027: FX Chamfered Screw 4.0mm x 52mm
• 00840124514706: Capital Fragment Guide Threaded