FDA 510(k)

Sistema de Fusion Cervical Anatómica PEEK™ con Nanotecnología

N.º K: K230936 · 2023-06-02

Fecha de decisión2023-06-02

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Anatomic PEEK™ Cervical Fusion System with Nanotechnology is the device name listed in this FDA 510(k) record. The listed applicant is Nanovis, LLC. It received FDA 510(k) clearance on 2023-06-02 under 510(k) number K230936. 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 Anatomic PEEK™ Cervical Fusion System with Nanotechnology?

Anatomic PEEK™ Cervical Fusion System with Nanotechnology is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is Nanovis, LLC. The 510(k) number is K230936.

When did Anatomic PEEK™ Cervical Fusion System with Nanotechnology receive FDA 510(k) clearance?

Anatomic PEEK™ Cervical Fusion System with Nanotechnology received FDA 510(k) clearance on 2023-06-02, under 510(k) number K230936.

Who is the listed applicant for Anatomic PEEK™ Cervical Fusion System with Nanotechnology?

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 Anatomic PEEK™ Cervical Fusion System with Nanotechnology?

The FDA product code for Anatomic PEEK™ Cervical Fusion System with Nanotechnology 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 Nanovis, LLC como solicitante

K241605Sistema Interbody de Adaptix™ PEEK con Nanotecnología; Sistema Espinal de Control™ PEEK con Nanotecnología K203452Nano FortiFix® System K191822Nano FortiCore, FortiCore K171312FortiCore®K161485Nanovis Intervertebral Body Fusion System and Forticore(R)K160874Nanovis Intervertebral Body Fusion System and FortiCore®

Ver todos los 7 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.