BioSphere MIS Putty (BioSphere MIS)

BioSphere MIS Putty (BioSphere MIS) is an FDA 510(k)-cleared medical device (K173301) manufactured by Synergy Biomedical, 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 January 18, 2018. Regulation: 8.