
Sonoma Orthopedic Products, Inc.
Free shipping on orders over $99 · 30-day returns
ENSPLINTRX BONE FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K071809) manufactured by Sonoma Orthopedic Products, 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 February 20, 2008. Regulation: 8.