FuzeFix Max FT CD-FT-2035

GUDID 00819034023080

Cannulated Reamer 3.5mm

FUSION ORTHOPEDICS, LLC

Surgical countersink, single-use

• Primary Device ID: 00819034023080
• NIH Device Record Key: 4f4b1f88-e514-499a-a727-058f4265c671
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FuzeFix Max FT
• Version Model Number: CD-FT-2035
• Catalog Number: CD-FT-2035
• Company DUNS: 080307067
• Company Name: FUSION ORTHOPEDICS, LLC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00819034023080 [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

[00819034023080]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-30
• Device Publish Date: 2019-04-22

On-Brand Devices [FuzeFix Max FT]

• 00819034028344: K-Wire Threaded 1.4mm
• 00819034028337: K-Wire Standard 1.4mm
• 00819034023189: Depth Gauge FT
• 00819034023158: Removal Driver 4.5mm
• 00819034023141: Removal Driver 3.5mm
• 00819034023134: Removal Driver 2.5mm
• 00819034023127: Torx Driver 4.5mm
• 00819034023110: Torx Driver 3.5mm
• 00819034023103: Torx Driver 2.5mm
• 00819034023097: Cannulated Reamer 4.5mm
• 00819034023080: Cannulated Reamer 3.5mm
• 00819034023073: Cannulated Reamer 2.5mm
• 00819034023066: Calibrated Drill Cannulated 3.0mm
• 00819034023059: Calibrated Drill Cannulated 2.1mm
• 00819034023042: Calibrated Drill Cannulated 1.7mm
• 00819034029822: Fully Threaded CompressionScrew FT 3.5mm x 55mm
• 00819034029815: Fully Threaded CompressionScrew FT 3.5mm x 45mm
• 00819034029808: Fully Threaded CompressionScrew FT 3.5mm x 35mm
• 00819034029792: Fully Threaded CompressionScrew FT 2.5mm x 50mm
• 00819034029785: Fully Threaded CompressionScrew FT 2.5mm x 45mm
• 00819034029778: Fully Threaded CompressionScrew FT 2.5mm x 35mm
• 00840124506664: Tissue Protector 3.5mm
• 00840124506657: Tissue Protector 4.5mm
• 00840124506640: Tissue Protector 2.5mm