
K2m, Inc.
Free shipping on orders over $99 · 30-day returns
RANGE SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K121630) manufactured by K2m, Inc.. 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 10, 2012. Regulation: 8.