FDA 510(k)

Cervical Interbody Fusion System

Número K: K160324 · 2016-05-05

Data da decisão2016-05-05

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cervical Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Evolution Spine, LLC. It received FDA 510(k) clearance on 2016-05-05 under 510(k) number K160324. 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 Cervical Interbody Fusion System?

Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2016-05-05. The listed applicant is Evolution Spine, LLC. The 510(k) number is K160324.

When did Cervical Interbody Fusion System receive FDA 510(k) clearance?

Cervical Interbody Fusion System received FDA 510(k) clearance on 2016-05-05, under 510(k) number K160324.

Who is the listed applicant for Cervical Interbody Fusion System?

The FDA 510(k) record lists Evolution Spine, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cervical Interbody Fusion System?

The FDA product code for Cervical Interbody Fusion System is ODP.

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Outros registros que listam Evolution Spine, LLC como candidato(a)

K182478Whistler Modular Pedicle Screw System K180755Vail ALIF Buttress Plate System K173375Sistema de Placa Cervical Anterior K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)

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.

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