FDA 510(k)

Hi-Fatigue Bone Cement

K-Number: K192394 · 2019-12-02

Decision Date2019-12-02

Product CodeLOD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Hi-Fatigue Bone Cement is a medical device manufactured by Osartis GmbH. It received FDA 510(k) clearance on 2019-12-02 under approval number K192394. 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 Hi-Fatigue Bone Cement?

Hi-Fatigue Bone Cement is a medical device that received FDA 510(k) clearance on 2019-12-02. It is manufactured by Osartis GmbH. The 510(k) number is K192394.

When was Hi-Fatigue Bone Cement approved by the FDA?

Hi-Fatigue Bone Cement received FDA 510(k) clearance on 2019-12-02, under approval number K192394.

What company makes Hi-Fatigue Bone Cement?

Hi-Fatigue Bone Cement is manufactured by Osartis GmbH.

What is the FDA product code for Hi-Fatigue Bone Cement?

The FDA product code for Hi-Fatigue Bone Cement is LOD.

Other Devices by Osartis GmbH

K192379Hi-Fatigue G Bone Cement K202458BonOs Inject, Pedicle screw kits, Cement pusher K210120BonOs HV, BonOs MV, BonOs LV K210125BonOs HV Genta, BonOs MV Genta, BonOs LV Genta K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds

Related Devices (Code: LOD)

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.