PLS (POSTERIOR LUMBAR SYSTEM)

PLS (POSTERIOR LUMBAR SYSTEM) is an FDA 510(k)-cleared medical device (K140787) manufactured by Sintea Plustek, 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 May 29, 2014. Regulation: 8.