FuzeFix Static Nail CD-SC-1016

GUDID 00840124521704

Cannulated Drill 1.6mm

FUSION ORTHOPEDICS, LLC

Cannulated surgical drill bit, single-use

• Primary Device ID: 00840124521704
• NIH Device Record Key: dacaa2ea-1f8c-4187-8db1-401f9bbbbaab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FuzeFix Static Nail
• Version Model Number: CD-SC-1016
• Catalog Number: CD-SC-1016
• 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	00840124521704 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170038

FDA Product Code

• HTW: Bit, Drill

Sterilization

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

[00840124521704]

Moist Heat or Steam Sterilization

[00840124521704]

Moist Heat or Steam Sterilization

[00840124521704]

Moist Heat or Steam Sterilization

[00840124521704]

Moist Heat or Steam Sterilization

[00840124521704]

Moist Heat or Steam Sterilization

[00840124521704]

Moist Heat or Steam Sterilization

[00840124521704]

Moist Heat or Steam Sterilization

[00840124521704]

Moist Heat or Steam Sterilization

[00840124521704]

Moist Heat or Steam Sterilization

[00840124521704]

Moist Heat or Steam Sterilization

[00840124521704]

Moist Heat or Steam Sterilization

[00840124521704]

Moist Heat or Steam Sterilization

[00840124521704]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-07
• Device Publish Date: 2025-09-29

Devices Manufactured by FUSION ORTHOPEDICS, LLC

• 00840124521704 - FuzeFix Static Nail: 2025-10-07Cannulated Drill 1.6mm
• 00840124521704 - FuzeFix Static Nail: 2025-10-07 Cannulated Drill 1.6mm
• 00840124514133 - TopLock: 2025-10-03 Tap and Drill Sleeve 3.5mm
• 00840124514140 - TopLock: 2025-10-03 Tap and Drill Sleeve 4.75mm
• 00840124521551 - FuzeFix Max FT: 2025-09-25 Chamfered Screw Jig Drill Guide Sleeve 2.6mm Left
• 00840124521568 - FuzeFix Max FT: 2025-09-25 Chamfered Screw Jig Drill Guide Sleeve 3.1mm Left
• 00840124521575 - FuzeFix Max FT: 2025-09-25 Chamfered Screws Jig Wire Sleeve 1.4mm
• 00840124521582 - FuzeFix Max FT: 2025-09-25 Chamfered Screw Jig Wire Sleeve 1.6mm
• 00840124521599 - FuzeFix Max FT: 2025-09-25 Chamfered Screw K-Wire 200mm (1.4mm)