510(k) K082419

REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1 by Intra-Lock International, Inc. — Product Code MQV

K082419 is an FDA 510(k) premarket notification submitted by Intra-Lock International, Inc. for the device "REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1". The FDA issued a decision of Substantially Equivalent on May 27, 2009. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Intra-Lock International, Inc. has at least 10 other 510(k) clearances on record.