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FDA 510(k)

Refobacin Bone Cement R (110034355)

K-Number: K254107 · 2026-04-15

ApplicantBiomet France
Decision Date2026-04-15
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Refobacin Bone Cement R (110034355) is the device name listed in this FDA 510(k) record. The listed applicant is Biomet France. It received FDA 510(k) clearance on 2026-04-15 under 510(k) number K254107. 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 Refobacin Bone Cement R (110034355)?

Refobacin Bone Cement R (110034355) is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is Biomet France. The 510(k) number is K254107.

When did Refobacin Bone Cement R (110034355) receive FDA 510(k) clearance?

Refobacin Bone Cement R (110034355) received FDA 510(k) clearance on 2026-04-15, under 510(k) number K254107.

Who is the listed applicant for Refobacin Bone Cement R (110034355)?

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

What is the FDA product code for Refobacin Bone Cement R (110034355)?

The FDA product code for Refobacin Bone Cement R (110034355) is LOD.

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.

K250760SPECTRUM 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 LtdaK211869OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cementOrmed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE

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.

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