FFX 11x3.5

GUDID 03770019503041

The FFX implant is a sterile, single patient use, long-term implantable devices consisting of a D-shaped cage made of titanium with an oval shape that is designed to be filled with bone graft. The top and bottom surfaces of the cage have sawtooth-shaped surface to improve fixation to the bone.

SC MEDICA

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 03770019503041
• NIH Device Record Key: fcda1bca-bd90-421a-a270-c916cacd80ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FFX 11x3.5
• Version Model Number: 57.000.50S
• 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	03770019503041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232468

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: 2024-11-21
• Device Publish Date: 2024-11-13

Devices Manufactured by SC MEDICA

• 03760418040667 - FFX Screw: 2025-12-04 The FFX screw is a self-compressive, self-tapping, headless and cannulated screw with a continuous progressive thread. It is mad
• 03760418040674 - FFX Screw: 2025-12-04 The FFX screw is a self-compressive, self-tapping, headless and cannulated screw with a continuous progressive thread. It is mad
• 03760418040681 - FFX Screw: 2025-12-04 The FFX screw is a self-compressive, self-tapping, headless and cannulated screw with a continuous progressive thread. It is mad
• 03760418040698 - FFX Screw: 2025-12-04 The FFX screw is a self-compressive, self-tapping, headless and cannulated screw with a continuous progressive thread. It is mad
• 03760418040704 - FFX Screw: 2025-12-04 The FFX screw is a self-compressive, self-tapping, headless and cannulated screw with a continuous progressive thread. It is mad
• 03760418040711 - FFX Screw: 2025-12-04 The FFX screw is a self-compressive, self-tapping, headless and cannulated screw with a continuous progressive thread. It is mad
• 03760418040728 - FFX Screw: 2025-12-04 The FFX screw is a self-compressive, self-tapping, headless and cannulated screw with a continuous progressive thread. It is mad
• 03760418040735 - FFX Screw: 2025-12-04 The FFX screw is a self-compressive, self-tapping, headless and cannulated screw with a continuous progressive thread. It is mad