510(k) K120760

LDR SPINE SPINETUNE TL SPINAL SYSTEM by Ldr Spine USA, Inc. — Product Code MNH

K120760 is an FDA 510(k) premarket notification submitted by Ldr Spine USA, Inc. for the device "LDR SPINE SPINETUNE TL SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on June 27, 2012. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Ldr Spine USA, Inc. has at least 10 other 510(k) clearances on record.