510(k) K130497

D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION by Linvatec Corporation D/B/A Conmed Linvatec — Product Code HBC

K130497 is an FDA 510(k) premarket notification submitted by Linvatec Corporation D/B/A Conmed Linvatec for the device "D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION". The FDA issued a decision of Substantially Equivalent on March 29, 2013. The device falls under product code HBC (Motor, Drill, Electric), a Class II device regulated under 21 CFR 882.4360. Linvatec Corporation D/B/A Conmed Linvatec has at least 3 other 510(k) clearances on record.