FDA 510(k)

TrueBalance™ Surgical System

Número K: K220830 · 2022-09-15

Data da decisão2022-09-15

Código do produtoONN

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

TrueBalance™ Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is These Three Medical, LLC. It received FDA 510(k) clearance on 2022-09-15 under 510(k) number K220830. The device is classified under product code ONN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TrueBalance™ Surgical System?

TrueBalance™ Surgical System is a medical device that received FDA 510(k) clearance on 2022-09-15. The listed applicant is These Three Medical, LLC. The 510(k) number is K220830.

When did TrueBalance™ Surgical System receive FDA 510(k) clearance?

TrueBalance™ Surgical System received FDA 510(k) clearance on 2022-09-15, under 510(k) number K220830.

Who is the listed applicant for TrueBalance™ Surgical System?

The FDA 510(k) record lists These Three Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TrueBalance™ Surgical System?

The FDA product code for TrueBalance™ Surgical System is ONN.

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