FDA 510(k)

Nanovis Intervertebral Body Fusion System and FortiCore®

N.º K: K160874 · 2016-06-28

Fecha de decisión2016-06-28

Código de productoMAX

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Nanovis Intervertebral Body Fusion System and FortiCore® is the device name listed in this FDA 510(k) record. The listed applicant is Nanovis, LLC. It received FDA 510(k) clearance on 2016-06-28 under 510(k) number K160874. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Nanovis Intervertebral Body Fusion System and FortiCore®?

Nanovis Intervertebral Body Fusion System and FortiCore® is a medical device that received FDA 510(k) clearance on 2016-06-28. The listed applicant is Nanovis, LLC. The 510(k) number is K160874.

When did Nanovis Intervertebral Body Fusion System and FortiCore® receive FDA 510(k) clearance?

Nanovis Intervertebral Body Fusion System and FortiCore® received FDA 510(k) clearance on 2016-06-28, under 510(k) number K160874.

Who is the listed applicant for Nanovis Intervertebral Body Fusion System and FortiCore®?

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

What is the FDA product code for Nanovis Intervertebral Body Fusion System and FortiCore®?

The FDA product code for Nanovis Intervertebral Body Fusion System and FortiCore® is MAX.

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 Nanovis, LLC como solicitante

K241605Sistema Interbody de Adaptix™ PEEK con Nanotecnología; Sistema Espinal de Control™ PEEK con Nanotecnología K230936Sistema de Fusion Cervical Anatómica PEEK™ con Nanotecnología K203452Nano FortiFix® System K191822Nano FortiCore, FortiCore K171312FortiCore®K161485Nanovis Intervertebral Body Fusion System and Forticore(R)

Ver todos los 7 dispositivos →

Dispositivos relacionados (Código: MAX)

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.