510(k) K080444

CONMED LINVATEC OSPREY DRILL SYSTEM by Conmed Linvatec — Product Code HBC

K080444 is an FDA 510(k) premarket notification submitted by Conmed Linvatec for the device "CONMED LINVATEC OSPREY DRILL SYSTEM". The FDA issued a decision of Substantially Equivalent on April 2, 2008. The device falls under product code HBC (Motor, Drill, Electric), a Class II device regulated under 21 CFR 882.4360. Conmed Linvatec has at least 10 other 510(k) clearances on record.