510(k) K210631

Avitus(r) Bone Harvester by Avitus Orthopaedics, Inc. — Product Code KNW

K210631 is an FDA 510(k) premarket notification submitted by Avitus Orthopaedics, Inc. for the device "Avitus(r) Bone Harvester". The FDA issued a decision of Substantially Equivalent on March 31, 2021. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Avitus Orthopaedics, Inc. has at least 4 other 510(k) clearances on record.