Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

Para-Fix External Fixation System

N.º K: K230067 · 2023-09-22

SolicitanteNew Paradigm Biomedical
Fecha de decisión2023-09-22
Código de productoLXT
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

Para-Fix External Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is New Paradigm Biomedical. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K230067. The device is classified under product code LXT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Para-Fix External Fixation System?

Para-Fix External Fixation System is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is New Paradigm Biomedical. The 510(k) number is K230067.

When did Para-Fix External Fixation System receive FDA 510(k) clearance?

Para-Fix External Fixation System received FDA 510(k) clearance on 2023-09-22, under 510(k) number K230067.

Who is the listed applicant for Para-Fix External Fixation System?

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

What is the FDA product code for Para-Fix External Fixation System?

The FDA product code for Para-Fix External Fixation System is LXT.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

↑