FDA 510(k)

Bone Cement-Normal Viscosity

Número K: K212729 · 2022-05-31

RequerenteBiomecanica Industria E Comerciode Produtos Ortopedicos Ltda

Data da decisão2022-05-31

Código do produtoLOD

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Bone Cement-Normal Viscosity is the device name listed in this FDA 510(k) record. The listed applicant is Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda. It received FDA 510(k) clearance on 2022-05-31 under 510(k) number K212729. 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 Bone Cement-Normal Viscosity?

Bone Cement-Normal Viscosity is a medical device that received FDA 510(k) clearance on 2022-05-31. The listed applicant is Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda. The 510(k) number is K212729.

When did Bone Cement-Normal Viscosity receive FDA 510(k) clearance?

Bone Cement-Normal Viscosity received FDA 510(k) clearance on 2022-05-31, under 510(k) number K212729.

Who is the listed applicant for Bone Cement-Normal Viscosity?

The FDA 510(k) record lists Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bone Cement-Normal Viscosity?

The FDA product code for Bone Cement-Normal Viscosity is LOD.

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