510(k) K202458

BonOs Inject, Pedicle screw kits, Cement pusher by Osartis GmbH — Product Code LOD

K202458 is an FDA 510(k) premarket notification submitted by Osartis GmbH for the device "BonOs Inject, Pedicle screw kits, Cement pusher". The FDA issued a decision of Substantially Equivalent on May 18, 2021. The device falls under product code LOD (Bone Cement), a Class II device regulated under 21 CFR 888.3027. Osartis GmbH has at least 5 other 510(k) clearances on record.