FDA 510(k)

Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System

N.º K: K182007 · 2018-12-07

SolicitanteRenovis Surgical Technologies

Fecha de decisión2018-12-07

Código de productoOVD

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System is the device name listed in this FDA 510(k) record. The listed applicant is Renovis Surgical Technologies. It received FDA 510(k) clearance on 2018-12-07 under 510(k) number K182007. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System?

Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System is a medical device that received FDA 510(k) clearance on 2018-12-07. The listed applicant is Renovis Surgical Technologies. The 510(k) number is K182007.

When did Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System receive FDA 510(k) clearance?

Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System received FDA 510(k) clearance on 2018-12-07, under 510(k) number K182007.

Who is the listed applicant for Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System?

The FDA 510(k) record lists Renovis Surgical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System?

The FDA product code for Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System is OVD.

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 Renovis Surgical Technologies como solicitante

K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee System K181655Renovis S180 Lateral Lumbar Interbody Fusion System K171543Renovis Surgical Hip Replacement System K170888Renovis S141 Lumbar Interbody Fusion System K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System

Dispositivos relacionados (Código: OVD)

K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF SystemINNO Holdings Inc. DBA Innovasis K261408SABER-XA SystemElevation Spine K261809Interwedge® Standalone LateralFoundation Surgical Group K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Placa de Cubierta Anteralign LSTyber Medical, LLC K254202MectaLIF 3D Metal AnteriorMedacta International S.A.

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.