510(k) K980817

PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L by Interpore Intl. — Product Code MQV

K980817 is an FDA 510(k) premarket notification submitted by Interpore Intl. for the device "PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L". The FDA issued a decision of Substantially Equivalent on September 25, 1998. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Interpore Intl. has at least 10 other 510(k) clearances on record.