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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.

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