FDA 510(k)

Modulift Vertebral Body Replacement (VBR) System

N.º K: K172032 · 2017-11-20

SolicitanteAesculap Implants Systems, Inc.

Fecha de decisión2017-11-20

Código de productoPLR

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Modulift Vertebral Body Replacement (VBR) System is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implants Systems, Inc.. It received FDA 510(k) clearance on 2017-11-20 under 510(k) number K172032. The device is classified under product code PLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Modulift Vertebral Body Replacement (VBR) System?

Modulift Vertebral Body Replacement (VBR) System is a medical device that received FDA 510(k) clearance on 2017-11-20. The listed applicant is Aesculap Implants Systems, Inc.. The 510(k) number is K172032.

When did Modulift Vertebral Body Replacement (VBR) System receive FDA 510(k) clearance?

Modulift Vertebral Body Replacement (VBR) System received FDA 510(k) clearance on 2017-11-20, under 510(k) number K172032.

Who is the listed applicant for Modulift Vertebral Body Replacement (VBR) System?

The FDA 510(k) record lists Aesculap Implants Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Modulift Vertebral Body Replacement (VBR) System?

The FDA product code for Modulift Vertebral Body Replacement (VBR) System is PLR.

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

Dispositivos relacionados (Código: PLR)

K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantAtlas Spine, Inc.K252560Atlas Spine HiRISE™ Expandable Cervical Corpectomy SystemAtlas Spine, Inc.K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC K221542Galileo Vertebral Body Replacement DeviceBright Spine K212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.K211320CAPRI Corpectomy Cage SystemK2m, Inc.

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.