510(k) K052098

CONNEXUS, .5CC, MODEL 023000-005 by Isotis Orthobiologics, Inc. — Product Code MQV

K052098 is an FDA 510(k) premarket notification submitted by Isotis Orthobiologics, Inc. for the device "CONNEXUS, .5CC, MODEL 023000-005". The FDA issued a decision of Substantially Equivalent on September 7, 2005. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Isotis Orthobiologics, Inc. has at least 9 other 510(k) clearances on record.