Boundary Anterior Lumbar Buttress Plate

Boundary Anterior Lumbar Buttress Plate is an FDA 510(k)-cleared medical device (K173091) manufactured by Nvision Biomedical Technologies, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 5, 2017. Regulation: 8.