Spine-Tech's premarket approval (PMA) for BAK/L accepted for filing:
This article was originally published in Clinica
Executive Summary
Spine-Tech (US) has received notification from the US FDA that the company's PMA application for the BAK/L interbody fusion system has been accepted for filing. The PMA has also been granted expedited review because the lower re-operation rate reported indicates a potential benefit to public health, Spine-Tech says.