FDA 510(k)

AOS Small Fragment Plating System

Número K: K161913 · 2016-11-04

RequerenteAdvanced Orthopaedic Solutions, Inc. (Aos)

Data da decisão2016-11-04

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

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Outros registros que listam Advanced Orthopaedic Solutions, Inc. (Aos) como candidato(a)

K181035AOS Small Fragment Plating System Lite K171606AOS Anterolateral Proximal Humeral Plate K163014AOS Small Bone Nailing System

Dispositivos Relacionados (Código: HRS)

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Fonte oficial

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