Osartis GmbH - FDA 510(k) Cleared Devices
Recent clearances: Hip Spacer Molds, BonOs Inject, Pedicle screw kits, Cement pusher, BonOs HV, BonOs MV, BonOs LV
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Osartis GmbH Orthopedic ✕
6 devices
Cleared
Nov 20, 2024
Hip Spacer Molds
Orthopedic
237d
Cleared
May 18, 2021
BonOs Inject, Pedicle screw kits, Cement pusher
Orthopedic
264d
Cleared
Mar 19, 2021
BonOs HV, BonOs MV, BonOs LV
Orthopedic
59d
Cleared
Mar 19, 2021
BonOs HV Genta, BonOs MV Genta, BonOs LV Genta
Orthopedic
59d
Cleared
Dec 02, 2019
Hi-Fatigue Bone Cement
Orthopedic
90d
Cleared
Nov 27, 2019
Hi-Fatigue G Bone Cement
Orthopedic
89d