FDA 510(k)

SpineKure Kyphoplasty System

Número K: K172871 · 2018-05-29

Data da decisão2018-05-29

Código do produtoNDN

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

SpineKure Kyphoplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Hanchang Co., Ltd.. It received FDA 510(k) clearance on 2018-05-29 under 510(k) number K172871. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SpineKure Kyphoplasty System?

SpineKure Kyphoplasty System is a medical device that received FDA 510(k) clearance on 2018-05-29. The listed applicant is Hanchang Co., Ltd.. The 510(k) number is K172871.

When did SpineKure Kyphoplasty System receive FDA 510(k) clearance?

SpineKure Kyphoplasty System received FDA 510(k) clearance on 2018-05-29, under 510(k) number K172871.

Who is the listed applicant for SpineKure Kyphoplasty System?

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

What is the FDA product code for SpineKure Kyphoplasty System?

The FDA product code for SpineKure Kyphoplasty System is NDN.

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