NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)

NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) is an FDA 510(k)-cleared medical device (K181772) manufactured by Ceterix Orthopaedics, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 31, 2018. Regulation: 8.