FDA 510(k) Applications Submitted by OSARTIS GmbH

FDA 510(k) Number Submission Date Device Name Applicant
K210120 01/19/2021 BonOs HV, BonOs MV, BonOs LV Osartis GmbH
K210125 01/19/2021 BonOs HV Genta, BonOs MV Genta, BonOs LV Genta OSARTIS GmbH
K240856 03/28/2024 Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds Osartis GmbH
K202458 08/27/2020 BonOs Inject, Pedicle screw kits, Cement pusher Osartis GmbH
K192379 08/30/2019 Hi-Fatigue G Bone Cement OSARTIS GmbH
K192394 09/03/2019 Hi-Fatigue Bone Cement OSARTIS GmbH


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