FDA 510(k)

Broca 2.1 x 255mm, 22mm Parar

Número K: K213072 · 2022-08-23

Data da decisão2022-08-23

Código do produtoHBE

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

2.1 x 255mm Drill, 22mm Stop is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Micofixation. It received FDA 510(k) clearance on 2022-08-23 under 510(k) number K213072. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 2.1 x 255mm Drill, 22mm Stop?

2.1 x 255mm Drill, 22mm Stop is a medical device that received FDA 510(k) clearance on 2022-08-23. The listed applicant is Biomet Micofixation. The 510(k) number is K213072.

When did 2.1 x 255mm Drill, 22mm Stop receive FDA 510(k) clearance?

2.1 x 255mm Drill, 22mm Stop received FDA 510(k) clearance on 2022-08-23, under 510(k) number K213072.

Who is the listed applicant for 2.1 x 255mm Drill, 22mm Stop?

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

What is the FDA product code for 2.1 x 255mm Drill, 22mm Stop?

The FDA product code for 2.1 x 255mm Drill, 22mm Stop is HBE.

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Outros registros que listam Biomet Micofixation como candidato(a)

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Dispositivos Relacionados (Código: HBE)

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