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FDA 510(k)

BonOs HV, BonOs MV, BonOs LV

K-Number: K210120 · 2021-03-19

ApplicantOsartis GmbH
Decision Date2021-03-19
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BonOs HV, BonOs MV, BonOs LV is the device name listed in this FDA 510(k) record. The listed applicant is Osartis GmbH. It received FDA 510(k) clearance on 2021-03-19 under 510(k) number K210120. 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, BonOs MV, BonOs LV?

BonOs HV, BonOs MV, BonOs LV is a medical device that received FDA 510(k) clearance on 2021-03-19. The listed applicant is Osartis GmbH. The 510(k) number is K210120.

When did BonOs HV, BonOs MV, BonOs LV receive FDA 510(k) clearance?

BonOs HV, BonOs MV, BonOs LV received FDA 510(k) clearance on 2021-03-19, under 510(k) number K210120.

Who is the listed applicant for BonOs HV, BonOs MV, BonOs LV?

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 BonOs HV, BonOs MV, BonOs LV?

The FDA product code for BonOs HV, BonOs MV, BonOs LV 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.

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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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