FDA 510(k)

Sistema de Placa de Fragmento Pequeño AOS

N.º K: K161913 · 2016-11-04

SolicitanteAdvanced Orthopaedic Solutions, Inc. (Aos)

Fecha de decisión2016-11-04

Código de productoHRS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

AOS Small Fragment Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Orthopaedic Solutions, Inc. (Aos). It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K161913. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AOS Small Fragment Plating System?

AOS Small Fragment Plating System is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Advanced Orthopaedic Solutions, Inc. (Aos). The 510(k) number is K161913.

When did AOS Small Fragment Plating System receive FDA 510(k) clearance?

AOS Small Fragment Plating System received FDA 510(k) clearance on 2016-11-04, under 510(k) number K161913.

Who is the listed applicant for AOS Small Fragment Plating System?

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

What is the FDA product code for AOS Small Fragment Plating System?

The FDA product code for AOS Small Fragment Plating System is HRS.

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. (Aos) como solicitante

K181035Sistema de Placa de Fragmento Pequeño AOS Lite K171606AOS Anterolateral Proximal Humeral Plate K163014Sistema de Clavo de hueso pequeño AOS

Dispositivos relacionados (Código: HRS)

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim Sirketi K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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.