510(k) K170539

Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm by Avitus Orthopaedics, Inc. — Product Code KNW

K170539 is an FDA 510(k) premarket notification submitted by Avitus Orthopaedics, Inc. for the device "Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm". The FDA issued a decision of Substantially Equivalent on March 20, 2017. 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.