FDA 510(k)

uCerv Flux-C 3D Porous Titanium Cervical Interbody

N.º K: K220696 · 2022-08-19

Fecha de decisión2022-08-19

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

uCerv Flux-C 3D Porous Titanium Cervical Interbody is the device name listed in this FDA 510(k) record. The listed applicant is Ulrich Medical USA. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K220696. 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 uCerv Flux-C 3D Porous Titanium Cervical Interbody?

uCerv Flux-C 3D Porous Titanium Cervical Interbody is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Ulrich Medical USA. The 510(k) number is K220696.

When did uCerv Flux-C 3D Porous Titanium Cervical Interbody receive FDA 510(k) clearance?

uCerv Flux-C 3D Porous Titanium Cervical Interbody received FDA 510(k) clearance on 2022-08-19, under 510(k) number K220696.

Who is the listed applicant for uCerv Flux-C 3D Porous Titanium Cervical Interbody?

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

What is the FDA product code for uCerv Flux-C 3D Porous Titanium Cervical Interbody?

The FDA product code for uCerv Flux-C 3D Porous Titanium Cervical Interbody 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 Ulrich Medical USA como solicitante

K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement K230614Cortium™K223274Momentum® MIS Posterior Spinal Fixation System K200845Navigation Module of the Momentum System K191932Momentum™ Posterior Spinal Fixation System K181921Solidity Vertebral Body Replacement

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.