510(k) K102265

LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM by Ldr Spine USA — Product Code KWQ

K102265 is an FDA 510(k) premarket notification submitted by Ldr Spine USA for the device "LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on September 29, 2010. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Ldr Spine USA has at least 10 other 510(k) clearances on record.