510(k) K050440

AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12 by Ceremed , Inc. — Product Code MTJ

K050440 is an FDA 510(k) premarket notification submitted by Ceremed , Inc. for the device "AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12". The FDA issued a decision of Substantially Equivalent on March 24, 2005. The device falls under product code MTJ (Wax, Bone), a Class U device. Ceremed , Inc. has at least 10 other 510(k) clearances on record.