FDA 510(k)

Sistema de Fusion Interespinal Cervical Altus Spine

N.º K: K172253 · 2017-11-21

Fecha de decisión2017-11-21

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Altus Spine Cervical Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Altus Partners, LLC. It received FDA 510(k) clearance on 2017-11-21 under 510(k) number K172253. 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 Altus Spine Cervical Interbody Fusion System?

Altus Spine Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2017-11-21. The listed applicant is Altus Partners, LLC. The 510(k) number is K172253.

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

Altus Spine Cervical Interbody Fusion System received FDA 510(k) clearance on 2017-11-21, under 510(k) number K172253.

Who is the listed applicant for Altus Spine Cervical Interbody Fusion System?

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

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

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

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Otros registros que enlistan a Altus Partners, LLC como solicitante

K243419Sistema de Navegación Altus Spine K211027Sistema de Clavo Pedicular Altus Spine K211837Sistema de Fusion Interespinal Independiente Altus Spine K210887Sistema de OCT Espinal Sochi Altus Spine K200922Sistema de Clavo Pedicular Altus Spine HA K200322Sistema de Clavo Pedicular Altus Spine

Ver todos los 16 dispositivos →

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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