510(k) K090507

MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM by Ldr Spine USA — Product Code MAX

K090507 is an FDA 510(k) premarket notification submitted by Ldr Spine USA for the device "MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM". The FDA issued a decision of Substantially Equivalent on June 25, 2009. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Ldr Spine USA has at least 10 other 510(k) clearances on record.