NOVOS-NAIL Limb Lengthening System (LLS)

NOVOS-NAIL Limb Lengthening System (LLS) is an FDA 510(k)-cleared medical device (K163653) manufactured by Smith & Nephew. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 12, 2017. Regulation: 8.