FDA 510(k)

Osteo-site Vertebral Balloon

N.º K: K200763 · 2020-08-12

Fecha de decisión2020-08-12

Código de productoHRX

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Osteo-site Vertebral Balloon is the device name listed in this FDA 510(k) record. The listed applicant is Izi Medical. It received FDA 510(k) clearance on 2020-08-12 under 510(k) number K200763. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Osteo-site Vertebral Balloon?

Osteo-site Vertebral Balloon is a medical device that received FDA 510(k) clearance on 2020-08-12. The listed applicant is Izi Medical. The 510(k) number is K200763.

When did Osteo-site Vertebral Balloon receive FDA 510(k) clearance?

Osteo-site Vertebral Balloon received FDA 510(k) clearance on 2020-08-12, under 510(k) number K200763.

Who is the listed applicant for Osteo-site Vertebral Balloon?

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

What is the FDA product code for Osteo-site Vertebral Balloon?

The FDA product code for Osteo-site Vertebral Balloon is HRX.

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: HRX)

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KG K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLC K253523Freedom DS™ Decompression SystemSpinal Simplicity K252546VantageTM Lumbar Decompression KitAllevion Medical, LLC K253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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.