FDA 510(k)

Sistema de Clavo de hueso pequeño AOS

N.º K: K163014 · 2017-01-24

SolicitanteAdvanced Orthopaedic Solutions, Inc. (Aos)

Fecha de decisión2017-01-24

Código de productoHSB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

AOS Small Bone Nailing 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 2017-01-24 under 510(k) number K163014. 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 Small Bone Nailing System?

AOS Small Bone Nailing System is a medical device that received FDA 510(k) clearance on 2017-01-24. The listed applicant is Advanced Orthopaedic Solutions, Inc. (Aos). The 510(k) number is K163014.

When did AOS Small Bone Nailing System receive FDA 510(k) clearance?

AOS Small Bone Nailing System received FDA 510(k) clearance on 2017-01-24, under 510(k) number K163014.

Who is the listed applicant for AOS Small Bone Nailing 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 Bone Nailing System?

The FDA product code for AOS Small Bone Nailing System is HSB.

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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 K161913Sistema de Placa de Fragmento Pequeño AOS

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

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