FDA 510(k)

BellaTek Bars

Número K: K260940 · 2026-09-21

Data da decisão2026-09-21

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

BellaTek Bars is the device name listed in this FDA 510(k) record. The listed applicant is ZimVie US Corp, LLC. It received FDA 510(k) clearance on 2026-09-21 under 510(k) number K260940. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BellaTek Bars?

BellaTek Bars is a medical device that received FDA 510(k) clearance on 2026-09-21. The listed applicant is ZimVie US Corp, LLC. The 510(k) number is K260940.

When did BellaTek Bars receive FDA 510(k) clearance?

BellaTek Bars received FDA 510(k) clearance on 2026-09-21, under 510(k) number K260940.

Who is the listed applicant for BellaTek Bars?

The FDA 510(k) record lists ZimVie US Corp, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BellaTek Bars?

The FDA product code for BellaTek Bars is NHA.

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