FFX 11x2.5

GUDID 03770019503003

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: 03770019503003
• NIH Device Record Key: b07e8eea-bc01-46f5-af44-60efe8533826
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FFX 11x2.5
• Version Model Number: 57.000.10S
• 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	03770019503003 [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

• 03760418040162 - FFX instruments tray: 2024-11-21 An instrument tray for FFX device implantation is a sterilizable container that securely holds and organizes surgical instrument
• 03760418040179 - FFX holder: 2024-11-21 Holder for FFX with tips
• 03760418040186 - Impactor: 2024-11-21 Impactor for FFX with tips
• 03760418040193 - Facet chisel: 2024-11-21 Straight facet chisel with titanium handle
• 03760418040209 - Rasp: 2024-11-21 Rasp with titanium handle
• 03760418040216 - Graft holder: 2024-11-21 Graft holder - 5 mm height
• 03760418040223 - Implant trial 11x 2.5: 2024-11-21 Implant trial with tip size 11x2.5
• 03760418040230 - Implant trial 11x 3: 2024-11-21 Implant trial with tip size 11x3