FuzeFix Chamfered Screws

GUDID 00840124514713

Capital Fragment Guide Handle

FUSION ORTHOPEDICS, LLC

Custom-made orthopaedic/craniofacial surgical guide

• Primary Device ID: 00840124514713
• NIH Device Record Key: 1969d0d5-37ea-4b27-ba7e-2f701d226467
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FuzeFix Chamfered Screws
• Version Model Number: TN-CS-9020
• 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	00840124514713 [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

[00840124514713]

Moist Heat or Steam Sterilization

[00840124514713]

Moist Heat or Steam Sterilization

[00840124514713]

Moist Heat or Steam Sterilization

[00840124514713]

Moist Heat or Steam Sterilization

[00840124514713]

Moist Heat or Steam Sterilization

[00840124514713]

Moist Heat or Steam Sterilization

[00840124514713]

Moist Heat or Steam Sterilization

[00840124514713]

Moist Heat or Steam Sterilization

[00840124514713]

Moist Heat or Steam Sterilization

[00840124514713]

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 Screws]

• 00840124510340: Chamfered Screw Cannulated Drill 3.0mm (2.1mm)
• 00840124510388: Chamfered Screw 4.0mm x 60mm
• 00840124510371: Chamfered Screw 4.0mm x 55mm
• 00840124510364: Chamfered Screw 3.5mm x 60mm
• 00840124510357: Chamfered Screw 3.5mm x 55mm
• 00840124510968: Depth Gauge Chamfered Screw
• 00840124509726: Chamfered Screw Reamer Cannulated 3.0mm
• 00840124509719: Chamfered Screw Cannulated Driver 3.0mm
• 00840124509702: Chamfered Screw 3.0mm x 55mm
• 00840124509696: Chamfered Screw 3.0mm x 50mm
• 00840124509689: Chamfered Screw 3.0mm x 48mm
• 00840124509672: Chamfered Screw 3.0mm x 46mm
• 00840124509665: Chamfered Screw 3.0mm x 45mm
• 00840124509658: Chamfered Screw 3.0mm x 44mm
• 00840124509641: Chamfered Screw 3.0mm x 42mm
• 00840124509634: Chamfered Screw 3.0mm x 40mm
• 00840124509627: Chamfered Screw 3.0mm x 38mm
• 00840124509610: Chamfered Screw 3.0mm x 36mm
• 00840124509603: Chamfered Screw 3.0mm x 35mm
• 00840124509597: Chamfered Screw 3.0mm x 34mm
• 00840124509580: Chamfered Screw 3.0mm x 32mm
• 00840124509573: Chamfered Screw 3.0mm x 30mm
• 00840124509566: Chamfered Screw 3.0mm x 28mm
• 00840124509559: Chamfered Screw 3.0mm x 26mm
• 00840124509542: Chamfered Screw 3.0mm x 24mm
• 00840124509535: Chamfered Screw 3.0mm x 22mm
• 00840124509528: Chamfered Screw 3.0mm x 20mm
• 00840124509511: Chamfered Screw 3.0mm x 18mm
• 00840124509504: Chamfered Screw 3.0mm x 16mm
• 00840124509498: Chamfered Screw 3.0mm x 14mm
• 00840124509481: Chamfered Screw 3.0mm x 12mm
• 00840124509474: Chamfered Screw 3.0mm x 10mm
• 00840124509450: Calibrated Wedge Burr, 2.2mm x 13mm
• 00840124509436: Rectangle Shannon Burr, 2.0mm x 13mm
• 00840124509412: Calibrated Shannon Burr, 2.0mm x 13mm
• 00840124509344: Chamfered Screw Reamer Cannulated 4.0mm
• 00840124509337: Chamfered Screw Reamer Cannulated 3.5mm
• 00840124509320: Chamfered Screw Calibrated Drill Cannulated 4.0mm (3.2 mm)
• 00840124509313: Chamfered Screw Calibrated Drill Cannulated 3.0mm (2.7mm)
• 00840124509306: Cannulated Driver, CS 4.0mm
• 00840124509290: Cannulated Driver, CS 3.5mm
• 00840124509283: Chamfered Screw 3.5mm x 50mm
• 00840124509276: Chamfered Screw 3.5mm x 45mm
• 00840124509269: Chamfered Screw 3.5mm x 40mm
• 00840124509252: Chamfered Screw 3.5mm x 35mm
• 00840124509245: Chamfered Screw 3.5mm x 30mm
• 00840124509238: Chamfered Screw 3.5mm x 28mm
• 00840124509221: Chamfered Screw 3.5mm x 26mm
• 00840124509214: Chamfered Screw 3.5mm x 24mm
• 00840124509207: Chamfered Screw 3.5mm x 22mm