510(k) K020204

TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODELS 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 8189 by Interpore Cross Intl. — Product Code MQP

K020204 is an FDA 510(k) premarket notification submitted by Interpore Cross Intl. for the device "TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODELS 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 8189". The FDA issued a decision of Substantially Equivalent on February 21, 2002. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Interpore Cross Intl. has at least 10 other 510(k) clearances on record.