FDA 510(k)

Peridot Intervertebral body fusion System

Número K: K192026 · 2019-11-26

Data da decisão2019-11-26

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Peridot Intervertebral body fusion 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 2019-11-26 under 510(k) number K192026. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Peridot Intervertebral body fusion System?

Peridot Intervertebral body fusion System is a medical device that received FDA 510(k) clearance on 2019-11-26. The listed applicant is Gbs Commonwealth Co., Ltd.. The 510(k) number is K192026.

When did Peridot Intervertebral body fusion System receive FDA 510(k) clearance?

Peridot Intervertebral body fusion System received FDA 510(k) clearance on 2019-11-26, under 510(k) number K192026.

Who is the listed applicant for Peridot Intervertebral body fusion 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 Peridot Intervertebral body fusion System?

The FDA product code for Peridot Intervertebral body fusion System is MAX.

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