FDA 510(k)

AOS Galileo® Trochanteric Nail System

Número K: K202099 · 2020-08-28

RequerenteAdvanced Orthopaedic Solutions, Inc.

Data da decisão2020-08-28

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

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Fonte oficial

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