RTS Flexible 1 MPJ Implant w/Grommets

RTS Flexible 1 MPJ Implant w/Grommets is an FDA 510(k)-cleared medical device (K153609) manufactured by In2bones USA, 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 7, 2016. Regulation: 8.