FDA 510(k)

Hi-Fatigue G Bone Cement

K-Number: K192379 · 2019-11-27

Decision Date2019-11-27

Product CodeLOD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Hi-Fatigue G Bone Cement is a medical device manufactured by Osartis GmbH. It received FDA 510(k) clearance on 2019-11-27 under approval number K192379. 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 G Bone Cement?

Hi-Fatigue G Bone Cement is a medical device that received FDA 510(k) clearance on 2019-11-27. It is manufactured by Osartis GmbH. The 510(k) number is K192379.

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

Hi-Fatigue G Bone Cement received FDA 510(k) clearance on 2019-11-27, under approval number K192379.

What company makes Hi-Fatigue G Bone Cement?

Hi-Fatigue G Bone Cement is manufactured by Osartis GmbH.

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

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

Other Devices by Osartis GmbH

K192394Hi-Fatigue 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

View on FDA Database →

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