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)

Sonoma Fifth Metatarsal Repair System

N.º K: K161371 · 2017-02-24

SolicitanteSonoma Orthopedic Products, Inc.
Fecha de decisión2017-02-24
Código de productoHSB
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

Sonoma Fifth Metatarsal Repair System is the device name listed in this FDA 510(k) record. The listed applicant is Sonoma Orthopedic Products, Inc.. It received FDA 510(k) clearance on 2017-02-24 under 510(k) number K161371. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Sonoma Fifth Metatarsal Repair System?

Sonoma Fifth Metatarsal Repair System is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is Sonoma Orthopedic Products, Inc.. The 510(k) number is K161371.

When did Sonoma Fifth Metatarsal Repair System receive FDA 510(k) clearance?

Sonoma Fifth Metatarsal Repair System received FDA 510(k) clearance on 2017-02-24, under 510(k) number K161371.

Who is the listed applicant for Sonoma Fifth Metatarsal Repair System?

The FDA 510(k) record lists Sonoma Orthopedic Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sonoma Fifth Metatarsal Repair System?

The FDA product code for Sonoma Fifth Metatarsal Repair System is HSB.

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

Dispositivos relacionados (Código: HSB)

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.

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbHK253080Sistema de Clavo Femoral AND Medical (PFNA01); Sistema de Clavo Femoral AND Medical (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices 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.

↑