
Ldr Spine USA
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LDR SPINE ROI INTERBODY FUSION SYSTEM is an FDA 510(k)-cleared medical device (K082262) 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 February 1, 2009. Regulation: 8.