FDA 510(k)

ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System

N.º K: K180980 · 2018-10-27

SolicitanteCamber Spine Technologies, LLC

Fecha de decisión2018-10-27

Código de productoNKB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System is the device name listed in this FDA 510(k) record. The listed applicant is Camber Spine Technologies, LLC. It received FDA 510(k) clearance on 2018-10-27 under 510(k) number K180980. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System?

ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System is a medical device that received FDA 510(k) clearance on 2018-10-27. The listed applicant is Camber Spine Technologies, LLC. The 510(k) number is K180980.

When did ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System receive FDA 510(k) clearance?

ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System received FDA 510(k) clearance on 2018-10-27, under 510(k) number K180980.

Who is the listed applicant for ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System?

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

What is the FDA product code for ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System?

The FDA product code for ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System is NKB.

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Otros registros que enlistan a Camber Spine Technologies, LLC como solicitante

K232256Sistema de Placa Toracolumbar Alcantara K203503Camber Sacroiliac (SI) Fixation System K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers K191584FORTICO Anterior Cervical Fixation System K180724SPIRA Open Matrix LLIF

Dispositivos relacionados (Código: NKB)

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix Medical K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

Fuente oficial

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