FDA 510(k)

AOS Calcaneal Plating System

Número K: K182466 · 2018-10-30

RequerenteAdvanced Orthopaedic Solutions

Data da decisão2018-10-30

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

AOS Calcaneal Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Orthopaedic Solutions. It received FDA 510(k) clearance on 2018-10-30 under 510(k) number K182466. 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 Calcaneal Plating System?

AOS Calcaneal Plating System is a medical device that received FDA 510(k) clearance on 2018-10-30. The listed applicant is Advanced Orthopaedic Solutions. The 510(k) number is K182466.

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

AOS Calcaneal Plating System received FDA 510(k) clearance on 2018-10-30, under 510(k) number K182466.

Who is the listed applicant for AOS Calcaneal Plating System?

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

What is the FDA product code for AOS Calcaneal Plating System?

The FDA product code for AOS Calcaneal Plating System is HRS.

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Fonte oficial

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