FDA 510(k)

CAVUX™ Cervical Cage

N.º K: K161642 · 2016-10-07

SolicitanteProvidence Medical Technology, Inc.

Fecha de decisión2016-10-07

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

CAVUX™ Cervical Cage is the device name listed in this FDA 510(k) record. The listed applicant is Providence Medical Technology, Inc.. It received FDA 510(k) clearance on 2016-10-07 under 510(k) number K161642. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CAVUX™ Cervical Cage?

CAVUX™ Cervical Cage is a medical device that received FDA 510(k) clearance on 2016-10-07. The listed applicant is Providence Medical Technology, Inc.. The 510(k) number is K161642.

When did CAVUX™ Cervical Cage receive FDA 510(k) clearance?

CAVUX™ Cervical Cage received FDA 510(k) clearance on 2016-10-07, under 510(k) number K161642.

Who is the listed applicant for CAVUX™ Cervical Cage?

The FDA 510(k) record lists Providence Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAVUX™ Cervical Cage?

The FDA product code for CAVUX™ Cervical Cage is ODP.

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Otros registros que enlistan a Providence Medical Technology, Inc. como solicitante

K261665CORUS™ Navigation System-GN K253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)K253190CORUS-LX Implant K251060CORUS™ Navigation System-GX K251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant K241035PMT Posterior Cervical Stabilization System (PCSS)

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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.

Fuente oficial

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