FDA 510(k)

Trax EX Anchor

Número K: K251750 · 2026-03-12

Data da decisão2026-03-12

Código do produtoMBI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Trax EX Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Trax Surgical, Inc.. It received FDA 510(k) clearance on 2026-03-12 under 510(k) number K251750. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Trax EX Anchor?

Trax EX Anchor is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Trax Surgical, Inc.. The 510(k) number is K251750.

When did Trax EX Anchor receive FDA 510(k) clearance?

Trax EX Anchor received FDA 510(k) clearance on 2026-03-12, under 510(k) number K251750.

Who is the listed applicant for Trax EX Anchor?

The FDA 510(k) record lists Trax Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Trax EX Anchor?

The FDA product code for Trax EX Anchor is MBI.

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