FDA 510(k)

SkeletonPlanner

Número K: K260206 · 2026-07-15

Data da decisão2026-07-15

Código do produtoQIH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

SkeletonPlanner is the device name listed in this FDA 510(k) record. The listed applicant is UPlanner B.V. - Presurgeo. It received FDA 510(k) clearance on 2026-07-15 under 510(k) number K260206. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SkeletonPlanner?

SkeletonPlanner is a medical device that received FDA 510(k) clearance on 2026-07-15. The listed applicant is UPlanner B.V. - Presurgeo. The 510(k) number is K260206.

When did SkeletonPlanner receive FDA 510(k) clearance?

SkeletonPlanner received FDA 510(k) clearance on 2026-07-15, under 510(k) number K260206.

Who is the listed applicant for SkeletonPlanner?

The FDA 510(k) record lists UPlanner B.V. - Presurgeo as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SkeletonPlanner?

The FDA product code for SkeletonPlanner is QIH.

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