510(k) K941285

ARTHREX GRAFT HARVESTING KIT by Arthrex, Inc. — Product Code KIJ

K941285 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "ARTHREX GRAFT HARVESTING KIT". The FDA issued a decision of Substantially Equivalent on November 14, 1994. The device falls under product code KIJ (Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Arthrex, Inc. has at least 10 other 510(k) clearances on record.