FuzeFix Chamfered Screw

GUDID 00840124514027

FX Chamfered Screw 4.0mm x 52mm

FUSION ORTHOPEDICS, LLC

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 00840124514027
• NIH Device Record Key: 19f6e1b6-bca7-4aa9-9025-7b5c62e7051f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FuzeFix Chamfered Screw
• Version Model Number: FX-CS-4052
• 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: true
• 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	00840124514027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170038

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00840124514027]

Moist Heat or Steam Sterilization

[00840124514027]

Moist Heat or Steam Sterilization

[00840124514027]

Moist Heat or Steam Sterilization

[00840124514027]

Moist Heat or Steam Sterilization

[00840124514027]

Moist Heat or Steam Sterilization

[00840124514027]

Moist Heat or Steam Sterilization

[00840124514027]

Moist Heat or Steam Sterilization

[00840124514027]

Moist Heat or Steam Sterilization

[00840124514027]

Moist Heat or Steam Sterilization

[00840124514027]

Moist Heat or Steam Sterilization

[00840124514027]

Moist Heat or Steam Sterilization

[00840124514027]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-03
• Device Publish Date: 2024-09-25

Devices Manufactured by FUSION ORTHOPEDICS, LLC

• 00840124514195 - PolyPrep: 2024-11-05 Push Pull
• 00840124514201 - FuzeFix Chamfered Screws: 2024-11-05 Manual Rasp Mirror
• 00840124514218 - PolyLock Midfoot: 2024-11-05 Distractor Compressor
• 00840124509405 - FuzeFix Jones: 2024-10-22 K-Wire Standard 1.6mm
• 00840124514102 - FuzeFix Chamfered Screws: 2024-10-14 Chamfered Screw Tray
• 00840124514096 - PolyLock Midfoot: 2024-10-09 Plate Bending Iron
• 00840124513754 - PolyLock Midfoot: 2024-10-07 MTP Prime Plate Universal Revision
• 00840124513761 - PolyLock Midfoot: 2024-10-07 MTP Prime Plate Short Left Revision