Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

Sistema Médico Addivation de Interbody Cervical

N.º K: K190291 · 2019-07-30

SolicitanteAddivation Medical, LLC
Fecha de decisión2019-07-30
Código de productoODP
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

Addivation Medical Cervical Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Addivation Medical, LLC. It received FDA 510(k) clearance on 2019-07-30 under 510(k) number K190291. 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 Addivation Medical Cervical Interbody System?

Addivation Medical Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2019-07-30. The listed applicant is Addivation Medical, LLC. The 510(k) number is K190291.

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

Addivation Medical Cervical Interbody System received FDA 510(k) clearance on 2019-07-30, under 510(k) number K190291.

Who is the listed applicant for Addivation Medical Cervical Interbody System?

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

What is the FDA product code for Addivation Medical Cervical Interbody System?

The FDA product code for Addivation Medical Cervical Interbody 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: ODP)

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.

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 SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX 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.

↑