Episurf Medical submits follow-up 510(k) application for Episealer® Patellofemoral System
Episurf Medical (NASDAQ: EPIS B) today announces a status update on the previously communicated 510(k) application to the US FDA for US market clearance for the Episealer® Patellofemoral System. The company has during Q1 had a dialogue with the FDA and has concluded that the necessary amendments are best addressed by a follow-up 510(k) application, addressing feedback from the FDA. The application will be filed within a few days and will undergo a review process with 90 days review time. Episealer® Patellofemoral System is an implant system with two opposing implants, intended for