FDA 510(k)

RIGEL 3DR Anterior Cervical Interbody Fusion System

N.º K: K200685 · 2020-06-11

Fecha de decisión2020-06-11

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

RIGEL 3DR Anterior Cervical Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is MiRus, LLC. It received FDA 510(k) clearance on 2020-06-11 under 510(k) number K200685. 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 RIGEL 3DR Anterior Cervical Interbody Fusion System?

RIGEL 3DR Anterior Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2020-06-11. The listed applicant is MiRus, LLC. The 510(k) number is K200685.

When did RIGEL 3DR Anterior Cervical Interbody Fusion System receive FDA 510(k) clearance?

RIGEL 3DR Anterior Cervical Interbody Fusion System received FDA 510(k) clearance on 2020-06-11, under 510(k) number K200685.

Who is the listed applicant for RIGEL 3DR Anterior Cervical Interbody Fusion System?

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

What is the FDA product code for RIGEL 3DR Anterior Cervical Interbody Fusion System?

The FDA product code for RIGEL 3DR Anterior Cervical Interbody Fusion System is ODP.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a MiRus, LLC como solicitante

K253444EUROPA™ Posterior Cervical Fusion Navigated Instruments K252733Sistema de Osteotomía Expansible ATLAS™K242516EUROPA™ Posterior Cervical Fusion System K241175MiRus MoRe Lumbar Plating System K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System K232481RIGEL™ 3DR Anterior Cervical Corpectomy System

Ver todos los 24 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

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.