FuzeFix Jones FX-JO-4650

GUDID 00840124507234

Headed Screw 4.5mm x 50mm

FUSION ORTHOPEDICS, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00840124507234
• NIH Device Record Key: c52e0eaa-59cc-4376-b1de-f9fd408d5931
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FuzeFix Jones
• Version Model Number: FX-JO-4650
• Catalog Number: FX-JO-4650
• 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	00840124507234 [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

[00840124507234]

Moist Heat or Steam Sterilization

[00840124507234]

Moist Heat or Steam Sterilization

[00840124507234]

Moist Heat or Steam Sterilization

[00840124507234]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-06
• Device Publish Date: 2022-11-28

On-Brand Devices [FuzeFix Jones]

• 00840124502000: Depth Gauge Jones
• 00840124501997: Guide 1.6mm and 3.2mm
• 00840124501980: Torx Driver 4.5mm
• 00840124501973: Cannulated Proximal Reamer 4.5mm
• 00840124501966: Calibrated Drill Cannulated 3.2mm
• 00840124501959: Solid Variable Pitch Screw JO 5.5mm x 70mm
• 00840124501942: Solid Variable Pitch Screw JO 5.5mm x 65mm
• 00840124501935: Solid Variable Pitch Screw JO 5.5mm x 60mm
• 00840124501928: Solid Variable Pitch Screw JO 5.5mm x 55mm
• 00840124501911: Solid Variable Pitch Screw JO 5.5mm x 50mm
• 00840124501904: Solid Variable Pitch Screw JO 5.5mm x 45mm
• 00840124501898: Solid Variable Pitch Screw JO 5.5mm x 40mm
• 00840124501881: Solid Variable Pitch Screw JO 4.5mm x 70mm
• 00840124501874: Solid Variable Pitch Screw JO 4.5mm x 65mm
• 00840124501867: Solid Variable Pitch Screw JO 4.5mm x 60mm
• 00840124501850: Solid Variable Pitch Screw JO 4.5mm x 55mm
• 00840124501843: Solid Variable Pitch Screw JO 4.5mm x 50mm
• 00840124501836: Solid Variable Pitch Screw JO 4.5mm x 45mm
• 00840124501829: Solid Variable Pitch Screw JO 4.5mm x 40mm
• 00840124507357: Guide 4.5mm and 5.5mm
• 00840124507340: Headed Jones 5.5mm x 70mm
• 00840124507333: Headed Screws 5.5mm x 65mm
• 00840124507326: Headed Screws 5.5mm x 60mm
• 00840124507319: Headed Screws 5.5mm x 55mm
• 00840124507302: Headed Screws 5.5mm x 50mm
• 00840124507296: Headed Screw 5.5mm x 45mm
• 00840124507289: Headed Screws 5.5mm x 40mm
• 00840124507272: Headed Screw 4.5mm x 70mm
• 00840124507265: Headed Jones 4.5mm x 65mm
• 00840124507258: Headed Screw 4.5mm x 60mm
• 00840124507241: Headed Screw 5.5mm x 55mm
• 00840124507234: Headed Screw 4.5mm x 50mm
• 00840124507227: Headed Screw 4.5mm x 45mm
• 00840124507210: Headed Screw 4.5mm x 40mm
• 00840124507203: 5.5mm Cannulated Tap
• 00840124507197: 4.5mm Cannulated Tap
• 00840124508217: 5.5mm Cannulated Tap
• 00840124507180: Headed Tray
• 00840124513686: Jones Headless Screw Tray
• 00840124509405: K-Wire Standard 1.6mm