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FDA 510(k)

Bone Cement Genta, Bone Cement HV, Bone Cement LV

K-Number: K211163 · 2023-01-09

ApplicantTecres S.P.A.
Decision Date2023-01-09
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Bone Cement Genta, Bone Cement HV, Bone Cement LV is the device name listed in this FDA 510(k) record. The listed applicant is Tecres S.P.A.. It received FDA 510(k) clearance on 2023-01-09 under 510(k) number K211163. 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 Bone Cement Genta, Bone Cement HV, Bone Cement LV?

Bone Cement Genta, Bone Cement HV, Bone Cement LV is a medical device that received FDA 510(k) clearance on 2023-01-09. The listed applicant is Tecres S.P.A.. The 510(k) number is K211163.

When did Bone Cement Genta, Bone Cement HV, Bone Cement LV receive FDA 510(k) clearance?

Bone Cement Genta, Bone Cement HV, Bone Cement LV received FDA 510(k) clearance on 2023-01-09, under 510(k) number K211163.

Who is the listed applicant for Bone Cement Genta, Bone Cement HV, Bone Cement LV?

The FDA 510(k) record lists Tecres S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bone Cement Genta, Bone Cement HV, Bone Cement LV?

The FDA product code for Bone Cement Genta, Bone Cement HV, Bone Cement LV is LOD.

Other records listing Tecres S.P.A. as applicant

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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, LLCK212729Bone Cement-Normal ViscosityBiomecanica Industria E Comerciode Produtos Ortopedicos LtdaK211869OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cementOrmed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE

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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