FDA 510(k)

EVOS Cabling System

Número K: K201497 · 2020-10-28

RequerentePioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

Data da decisão2020-10-28

Código do produtoJDQ

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

EVOS Cabling System is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). It received FDA 510(k) clearance on 2020-10-28 under 510(k) number K201497. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EVOS Cabling System?

EVOS Cabling System is a medical device that received FDA 510(k) clearance on 2020-10-28. The listed applicant is Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). The 510(k) number is K201497.

When did EVOS Cabling System receive FDA 510(k) clearance?

EVOS Cabling System received FDA 510(k) clearance on 2020-10-28, under 510(k) number K201497.

Who is the listed applicant for EVOS Cabling System?

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

What is the FDA product code for EVOS Cabling System?

The FDA product code for EVOS Cabling System is JDQ.

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Fonte oficial

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