FDA 510(k)

ProRib Fixation System

Número K: K261892 · 2026-09-23

Data da decisão2026-09-23

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ProRib Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Costa Surgical, Inc.. It received FDA 510(k) clearance on 2026-09-23 under 510(k) number K261892. 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 ProRib Fixation System?

ProRib Fixation System is a medical device that received FDA 510(k) clearance on 2026-09-23. The listed applicant is Costa Surgical, Inc.. The 510(k) number is K261892.

When did ProRib Fixation System receive FDA 510(k) clearance?

ProRib Fixation System received FDA 510(k) clearance on 2026-09-23, under 510(k) number K261892.

Who is the listed applicant for ProRib Fixation System?

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

What is the FDA product code for ProRib Fixation System?

The FDA product code for ProRib Fixation System is HRS.

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