www.fdanews.com/articles/205449-longeviti-gets-fdas-510k-clearance-for-its-implantable-clearfit-cover
Longeviti Gets FDA’s 510(k) Clearance for Its Implantable ClearFit Cover
November 22, 2021
Baltimore, Md.-based Longeviti Neuro Solutions has received the FDA’s 510(k) clearance for its ClearFit OTS (off-the-shelf) implantable prosthetics for correcting cranium bone voids.
The cranial implant, which is designed to help surgeons address urgent reconstructive clinical needs, is made of polymethyl-methacrylate, a sonolucent, biocompatible material that has been used in clinics for more than 40 years.
The implantable device allows the use of ultrasound for postoperative imaging, reducing the patient’s radiation exposure.