FDA 510(k)

Twist Drills

Número K: K213208 · 2021-12-23

Data da decisão2021-12-23

Código do produtoHBE

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Twist Drills is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Microfixation. It received FDA 510(k) clearance on 2021-12-23 under 510(k) number K213208. 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 Twist Drills?

Twist Drills is a medical device that received FDA 510(k) clearance on 2021-12-23. The listed applicant is Biomet Microfixation. The 510(k) number is K213208.

When did Twist Drills receive FDA 510(k) clearance?

Twist Drills received FDA 510(k) clearance on 2021-12-23, under 510(k) number K213208.

Who is the listed applicant for Twist Drills?

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

What is the FDA product code for Twist Drills?

The FDA product code for Twist Drills is HBE.

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Fonte oficial

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