FDA 510(k)

Solidex® Ti-Links and Screws

Número K: K251515 · 2026-02-10

Data da decisão2026-02-10

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Solidex® Ti-Links and Screws is the device name listed in this FDA 510(k) record. The listed applicant is CreoDent Hudson Valley. It received FDA 510(k) clearance on 2026-02-10 under 510(k) number K251515. 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 Solidex® Ti-Links and Screws?

Solidex® Ti-Links and Screws is a medical device that received FDA 510(k) clearance on 2026-02-10. The listed applicant is CreoDent Hudson Valley. The 510(k) number is K251515.

When did Solidex® Ti-Links and Screws receive FDA 510(k) clearance?

Solidex® Ti-Links and Screws received FDA 510(k) clearance on 2026-02-10, under 510(k) number K251515.

Who is the listed applicant for Solidex® Ti-Links and Screws?

The FDA 510(k) record lists CreoDent Hudson Valley as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Solidex® Ti-Links and Screws?

The FDA product code for Solidex® Ti-Links and Screws is NHA.

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Fonte oficial

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