FDA 510(k)

JASPER Spinal Fixation System

Número K: K173645 · 2018-07-23

Data da decisão2018-07-23

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

JASPER Spinal Fixation 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 2018-07-23 under 510(k) number K173645. 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 JASPER Spinal Fixation System?

JASPER Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2018-07-23. The listed applicant is Gbs Commonwealth Co., Ltd.. The 510(k) number is K173645.

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

JASPER Spinal Fixation System received FDA 510(k) clearance on 2018-07-23, under 510(k) number K173645.

Who is the listed applicant for JASPER Spinal Fixation 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 JASPER Spinal Fixation System?

The FDA product code for JASPER Spinal Fixation System is NKB.

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Fonte oficial

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