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FDA 510(k)

OrthoEasy Pal; OrthoEasy Pal Long Neck

K-Number: K260268 · 2026-05-19

ApplicantBernhard Förster GmbH (Bernhard Foerster Ltd.)
Decision Date2026-05-19
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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