FDA 510(k)

PC Fix System

Número K: K260411 · 2026-04-24

Data da decisão2026-04-24

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

PC Fix System is the device name listed in this FDA 510(k) record. The listed applicant is Chest Wall Innovations, Inc.. It received FDA 510(k) clearance on 2026-04-24 under 510(k) number K260411. 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 PC Fix System?

PC Fix System is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Chest Wall Innovations, Inc.. The 510(k) number is K260411.

When did PC Fix System receive FDA 510(k) clearance?

PC Fix System received FDA 510(k) clearance on 2026-04-24, under 510(k) number K260411.

Who is the listed applicant for PC Fix System?

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

What is the FDA product code for PC Fix System?

The FDA product code for PC Fix System is HRS.

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