510(k) K102331

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

K102331 is an FDA 510(k) premarket notification submitted by Ldr Spine USA for the device "LDR SPINE USA SPINETUNE TL SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on October 15, 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.