FDA 510(k)

GS Medical AnyPlus PEEK Cage System

Número K: K200592 · 2020-08-10

Data da decisão2020-08-10

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

GS Medical AnyPlus PEEK Cage System is the device name listed in this FDA 510(k) record. The listed applicant is GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-08-10 under 510(k) number K200592. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the GS Medical AnyPlus PEEK Cage System?

GS Medical AnyPlus PEEK Cage System is a medical device that received FDA 510(k) clearance on 2020-08-10. The listed applicant is GS Medical Co., Ltd.. The 510(k) number is K200592.

When did GS Medical AnyPlus PEEK Cage System receive FDA 510(k) clearance?

GS Medical AnyPlus PEEK Cage System received FDA 510(k) clearance on 2020-08-10, under 510(k) number K200592.

Who is the listed applicant for GS Medical AnyPlus PEEK Cage System?

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

What is the FDA product code for GS Medical AnyPlus PEEK Cage System?

The FDA product code for GS Medical AnyPlus PEEK Cage System is ODP.

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Outros registros que listam GS Medical Co., Ltd. como candidato(a)

K254260The VEGA Cervical Screw System K243073Sistema de Instrumentos Navegados AnyPlus K241738PYXIS 3D Titanium Cervical Cage system K240350AnyPlus II Sistemas de Fixação Espinal K231808QUASAR Standalone ACIF System K223868PYXIS 3D Titanium Cage System

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Fonte oficial

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