FDA 510(k)

Origin™ Anterior Cervical Plate System

N.º K: K193494 · 2020-04-06

SolicitanteOrthopaedic & Spine Development

Fecha de decisión2020-04-06

Código de productoKWQ

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Origin™ Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Orthopaedic & Spine Development. It received FDA 510(k) clearance on 2020-04-06 under 510(k) number K193494. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Origin™ Anterior Cervical Plate System?

Origin™ Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2020-04-06. The listed applicant is Orthopaedic & Spine Development. The 510(k) number is K193494.

When did Origin™ Anterior Cervical Plate System receive FDA 510(k) clearance?

Origin™ Anterior Cervical Plate System received FDA 510(k) clearance on 2020-04-06, under 510(k) number K193494.

Who is the listed applicant for Origin™ Anterior Cervical Plate System?

The FDA 510(k) record lists Orthopaedic & Spine Development as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Origin™ Anterior Cervical Plate System?

The FDA product code for Origin™ Anterior Cervical Plate System is KWQ.

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: KWQ)

K262149corra® cervical plating systemCarlsmed, Inc.K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC

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.