External Remote Controller ERC 4P

External Remote Controller ERC 4P is an FDA 510(k)-cleared medical device (K202348) manufactured by Nuvasive Specialized Orthopedics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 21, 2020. Regulation: 8.