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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
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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