Balanced Knee Revision System - Offset Junction Box

Balanced Knee Revision System - Offset Junction Box is an FDA 510(k)-cleared medical device (K180743) manufactured by Ortho Development Corporation. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 19, 2018. Regulation: 8.