FDA 510(k)

Prase MIS Spinal System

Número K: K182059 · 2018-10-04

Data da decisão2018-10-04

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Prase MIS Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Gbs Commonwealth Co., Ltd.. It received FDA 510(k) clearance on 2018-10-04 under 510(k) number K182059. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Prase MIS Spinal System?

Prase MIS Spinal System is a medical device that received FDA 510(k) clearance on 2018-10-04. The listed applicant is Gbs Commonwealth Co., Ltd.. The 510(k) number is K182059.

When did Prase MIS Spinal System receive FDA 510(k) clearance?

Prase MIS Spinal System received FDA 510(k) clearance on 2018-10-04, under 510(k) number K182059.

Who is the listed applicant for Prase MIS Spinal System?

The FDA 510(k) record lists Gbs Commonwealth Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prase MIS Spinal System?

The FDA product code for Prase MIS Spinal System is NKB.

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Fonte oficial

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