PISCES-SA Standalone ALIF Interbody System

PISCES-SA Standalone ALIF Interbody System is an FDA 510(k)-cleared medical device (K213935) manufactured by Osseus Fusion Systems. 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 5, 2022. Regulation: 8.