510(k) K121103

LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S by Ldr Spine USA, Inc. — Product Code NKB

K121103 is an FDA 510(k) premarket notification submitted by Ldr Spine USA, Inc. for the device "LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S". The FDA issued a decision of Substantially Equivalent on August 24, 2012. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Ldr Spine USA, Inc. has at least 10 other 510(k) clearances on record.