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FDA 510(k)

Hi-Fatigue Bone Cement

K-Number: K192394 · 2019-12-02

ApplicantOsartis GmbH
Decision Date2019-12-02
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Hi-Fatigue Bone Cement is the device name listed in this FDA 510(k) record. The listed applicant is Osartis GmbH. It received FDA 510(k) clearance on 2019-12-02 under 510(k) 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. The listed applicant is Osartis GmbH. The 510(k) number is K192394.

When did Hi-Fatigue Bone Cement receive FDA 510(k) clearance?

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

Who is the listed applicant for Hi-Fatigue Bone Cement?

The FDA 510(k) record lists Osartis GmbH as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Osartis GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsK202458BonOs Inject, Pedicle screw kits, Cement pusherK210125BonOs HV Genta, BonOs MV Genta, BonOs LV GentaK210120BonOs HV, BonOs MV, BonOs LVK192379Hi-Fatigue G Bone Cement

Related Devices (Code: LOD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254107Refobacin Bone Cement R (110034355)Biomet FranceK250760SPECTRUM GV Bone CementOsteoremedies, LLCK241674OSTEOPAL® VHeraeus Medical GmbHK231556SPECTRUM® GV Bone CementOsteoremedies, LLCK211163Bone Cement Genta, Bone Cement HV, Bone Cement LVTecres S.P.A.K212729Bone Cement-Normal ViscosityBiomecanica Industria E Comerciode Produtos Ortopedicos Ltda

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.

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