ChoiceSpine TigerShark™ M, Modular Interbody System

ChoiceSpine TigerShark™ M, Modular Interbody System is an FDA 510(k)-cleared medical device (K220953) manufactured by Choice Spine, 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 September 12, 2022. Regulation: 8.