FDA 510(k)

Sistema de Gaiola Cervical PEEK AnyPlus®

Número K: K153517 · 2016-06-24

Data da decisão2016-06-24

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

AnyPlus® Cervical 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 2016-06-24 under 510(k) number K153517. 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 AnyPlus® Cervical PEEK Cage System?

AnyPlus® Cervical PEEK Cage System is a medical device that received FDA 510(k) clearance on 2016-06-24. The listed applicant is GS Medical Co., Ltd.. The 510(k) number is K153517.

When did AnyPlus® Cervical PEEK Cage System receive FDA 510(k) clearance?

AnyPlus® Cervical PEEK Cage System received FDA 510(k) clearance on 2016-06-24, under 510(k) number K153517.

Who is the listed applicant for AnyPlus® Cervical 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 AnyPlus® Cervical PEEK Cage System?

The FDA product code for AnyPlus® Cervical 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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Dispositivos Relacionados (Código: ODP)

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker Spine K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.

Fonte oficial

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