510(k) K082795

SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT by Interventional Spine, Inc. — Product Code MRW

K082795 is an FDA 510(k) premarket notification submitted by Interventional Spine, Inc. for the device "SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT". The FDA issued a decision of Substantially Equivalent on December 12, 2008. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. Interventional Spine, Inc. has at least 7 other 510(k) clearances on record.