
Ldr Spine USA
Free shipping on orders over $99 · 30-day returns
MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM is an FDA 510(k)-cleared medical device (K090507) manufactured by Ldr Spine USA. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 24, 2009. Regulation: 8.