activL® Next Generation Instrumentation

activL® Next Generation Instrumentation is an FDA 510(k)-cleared medical device (K231769) manufactured by Aesculap Implants Systems, 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 July 12, 2023. Regulation: 8.