FDA 510(k)

Exalta Proximal Tibia Plating System

Número K: K261207 · 2026-06-12

Data da decisão2026-06-12

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Exalta Proximal Tibia Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Tyber Medical, LLC. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K261207. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Exalta Proximal Tibia Plating System?

Exalta Proximal Tibia Plating System is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Tyber Medical, LLC. The 510(k) number is K261207.

When did Exalta Proximal Tibia Plating System receive FDA 510(k) clearance?

Exalta Proximal Tibia Plating System received FDA 510(k) clearance on 2026-06-12, under 510(k) number K261207.

Who is the listed applicant for Exalta Proximal Tibia Plating System?

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

What is the FDA product code for Exalta Proximal Tibia Plating System?

The FDA product code for Exalta Proximal Tibia Plating System is HRS.

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Fonte oficial

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