www.fdanews.com/articles/201063-fda-gives-new-clearance-for-longeviti-implant
FDA Gives New Clearance for Longeviti Implant
January 28, 2021
The FDA has granted an additional 510(k) marketing clearance for Longeviti Neuro Solutions’ ClearFit neuro-reconstructive implant.
The ClearFit poduct is an implantable prosthetic that is tailored to the patient’s specific anatomy. It is cleared to correct and restore bony voids and cranial defects.
The new clearance allows the implant, which is used by surgeons to reconstruct cranial and facial bones, to be used in post-operative ultrasound imaging.