FDA 510(k)

OrthoEasy Pal; OrthoEasy Pal Long Neck

Número K: K260268 · 2026-05-19

RequerenteBernhard Förster GmbH (Bernhard Foerster Ltd.)

Data da decisão2026-05-19

Código do produtoOAT

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

OrthoEasy Pal; OrthoEasy Pal Long Neck is the device name listed in this FDA 510(k) record. The listed applicant is Bernhard Förster GmbH (Bernhard Foerster Ltd.). It received FDA 510(k) clearance on 2026-05-19 under 510(k) number K260268. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OrthoEasy Pal; OrthoEasy Pal Long Neck?

OrthoEasy Pal; OrthoEasy Pal Long Neck is a medical device that received FDA 510(k) clearance on 2026-05-19. The listed applicant is Bernhard Förster GmbH (Bernhard Foerster Ltd.). The 510(k) number is K260268.

When did OrthoEasy Pal; OrthoEasy Pal Long Neck receive FDA 510(k) clearance?

OrthoEasy Pal; OrthoEasy Pal Long Neck received FDA 510(k) clearance on 2026-05-19, under 510(k) number K260268.

Who is the listed applicant for OrthoEasy Pal; OrthoEasy Pal Long Neck?

The FDA 510(k) record lists Bernhard Förster GmbH (Bernhard Foerster Ltd.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OrthoEasy Pal; OrthoEasy Pal Long Neck?

The FDA product code for OrthoEasy Pal; OrthoEasy Pal Long Neck is OAT.

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