Adaptable Ortho Innovations Intramedullary Nail System

Adaptable Ortho Innovations Intramedullary Nail System is an FDA 510(k)-cleared medical device (K210285) manufactured by Adaptable Ortho Innovations, 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 March 17, 2021. Regulation: 8.