FDA 510(k)

AOS Small Bone Nailing System

Número K: K163014 · 2017-01-24

RequerenteAdvanced Orthopaedic Solutions, Inc. (Aos)

Data da decisão2017-01-24

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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