FDA 510(k)

Refobacin Bone Cement R (110034355)

Número K: K254107 · 2026-04-15

Data da decisão2026-04-15

Código do produtoLOD

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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