FFX Screw

GUDID 03760418040698

The FFX screw is a self-compressive, self-tapping, headless and cannulated screw with a continuous progressive thread. It is made of titanium alloy (EN ISO 5832-3). It is provided sterile and intended for long-term implantation. FFX Screw D 4mm-L16.0mm

SC MEDICA

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 03760418040698
• NIH Device Record Key: dd60c435-988b-4574-a565-3a39811f7506
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FFX Screw
• Version Model Number: 58.540.16S
• Company DUNS: 267135902
• Company Name: SC MEDICA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	03760418040698 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252153

FDA Product Code

• MRW: System, Facet Screw Spinal Device

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-04
• Device Publish Date: 2025-11-26

On-Brand Devices [FFX Screw ]

• 03760418040995: The FFX screw is a self-compressive, self-tapping, headless and cannulated screw with a continuo
• 03760418040940: The FFX screw is a self-compressive, self-tapping, headless and cannulated screw with a continuo
• 03760418040896: The FFX screw is a self-compressive, self-tapping, headless and cannulated screw with a continuo
• 03760418040773: The FFX screw is a self-compressive, self-tapping, headless and cannulated screw with a continuo
• 03760418040766: The FFX screw is a self-compressive, self-tapping, headless and cannulated screw with a continuo
• 03760418040759: The FFX screw is a self-compressive, self-tapping, headless and cannulated screw with a continuo
• 03760418040742: The FFX screw is a self-compressive, self-tapping, headless and cannulated screw with a continuo
• 03760418040735: The FFX screw is a self-compressive, self-tapping, headless and cannulated screw with a continuo
• 03760418040728: The FFX screw is a self-compressive, self-tapping, headless and cannulated screw with a continuo
• 03760418040711: The FFX screw is a self-compressive, self-tapping, headless and cannulated screw with a continuo
• 03760418040704: The FFX screw is a self-compressive, self-tapping, headless and cannulated screw with a continuo
• 03760418040698: The FFX screw is a self-compressive, self-tapping, headless and cannulated screw with a continuo
• 03760418040681: The FFX screw is a self-compressive, self-tapping, headless and cannulated screw with a continuo
• 03760418040674: The FFX screw is a self-compressive, self-tapping, headless and cannulated screw with a continuo
• 03760418040667: The FFX screw is a self-compressive, self-tapping, headless and cannulated screw with a continuo