FDA 510(k)

AOS Galileo™ Trochanteric Nail System

N.º K: K202099 · 2020-08-28

SolicitanteAdvanced Orthopaedic Solutions, Inc.

Fecha de decisión2020-08-28

Código de productoHSB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

AOS Galileo™ Trochanteric Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Orthopaedic Solutions, Inc.. It received FDA 510(k) clearance on 2020-08-28 under 510(k) number K202099. 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 AOS Galileo™ Trochanteric Nail System?

AOS Galileo™ Trochanteric Nail System is a medical device that received FDA 510(k) clearance on 2020-08-28. The listed applicant is Advanced Orthopaedic Solutions, Inc.. The 510(k) number is K202099.

When did AOS Galileo™ Trochanteric Nail System receive FDA 510(k) clearance?

AOS Galileo™ Trochanteric Nail System received FDA 510(k) clearance on 2020-08-28, under 510(k) number K202099.

Who is the listed applicant for AOS Galileo™ Trochanteric Nail System?

The FDA 510(k) record lists Advanced Orthopaedic Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AOS Galileo™ Trochanteric Nail System?

The FDA product code for AOS Galileo™ Trochanteric Nail 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_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

Otros registros que enlistan a Advanced Orthopaedic Solutions, Inc. como solicitante

K202489AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System K191598AOS ES Retrograde Femoral Nail K160409AOS Anterolateral Proximal Humeral Plate

Dispositivos relacionados (Código: HSB)

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbH K253080Sistema 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 Orthopedics K253155Fule 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.