Pisces™-SA STANDALONE ALIF Interbody System

Pisces™-SA STANDALONE ALIF Interbody System is an FDA 510(k)-cleared medical device (K223413) 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 February 9, 2023. Regulation: 8.