FDA 510(k)

BonOs HV Genta, BonOs MV Genta, BonOs LV Genta

K-Number: K210125 · 2021-03-19

Decision Date2021-03-19

Product CodeLOD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

BonOs HV Genta, BonOs MV Genta, BonOs LV Genta is a medical device manufactured by Osartis GmbH. It received FDA 510(k) clearance on 2021-03-19 under approval number K210125. The device is classified under product code LOD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BonOs HV Genta, BonOs MV Genta, BonOs LV Genta?

BonOs HV Genta, BonOs MV Genta, BonOs LV Genta is a medical device that received FDA 510(k) clearance on 2021-03-19. It is manufactured by Osartis GmbH. The 510(k) number is K210125.

When was BonOs HV Genta, BonOs MV Genta, BonOs LV Genta approved by the FDA?

BonOs HV Genta, BonOs MV Genta, BonOs LV Genta received FDA 510(k) clearance on 2021-03-19, under approval number K210125.

What company makes BonOs HV Genta, BonOs MV Genta, BonOs LV Genta?

BonOs HV Genta, BonOs MV Genta, BonOs LV Genta is manufactured by Osartis GmbH.

What is the FDA product code for BonOs HV Genta, BonOs MV Genta, BonOs LV Genta?

The FDA product code for BonOs HV Genta, BonOs MV Genta, BonOs LV Genta is LOD.

Other Devices by Osartis GmbH

K192394Hi-Fatigue Bone Cement K192379Hi-Fatigue G Bone Cement K202458BonOs Inject, Pedicle screw kits, Cement pusher K210120BonOs HV, BonOs MV, BonOs LV K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds

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K153737OSTEOPAL plusHeraeus Medical GmbH K172408Biomet Bone Cement RBiomet, Inc. K170802TRAUMACEM V+ Injectable Bone CementSynthes (USA) Products, LLC K171540Refobacin Bone Cement RBiomet, Inc. K182260PALACOS MVHeraeus Medical GmbH K173494OrthoSteady G Bone CementG21, S.R.L.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.