510(k) K100575

LDR SPINE USA SPINE TUNE TL SPINE SYSTEM by Ldr Spine USA — Product Code MNI

K100575 is an FDA 510(k) premarket notification submitted by Ldr Spine USA for the device "LDR SPINE USA SPINE TUNE TL SPINE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 31, 2010. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Ldr Spine USA has at least 10 other 510(k) clearances on record.