Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate)

Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate) is an FDA 510(k)-cleared medical device (K171893) manufactured by Bluestone Synergy. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 7, 2017. Regulation: 8.