FDA 510(k)

Valkyrie Thoracic Fixation System

Número K: K232515 · 2023-12-08

RequerenteJm Longyear Manufacturing, LLC D/B/A Able Medical Devices

Data da decisão2023-12-08

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Valkyrie Thoracic Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices. It received FDA 510(k) clearance on 2023-12-08 under 510(k) number K232515. 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 Valkyrie Thoracic Fixation System?

Valkyrie Thoracic Fixation System is a medical device that received FDA 510(k) clearance on 2023-12-08. The listed applicant is Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices. The 510(k) number is K232515.

When did Valkyrie Thoracic Fixation System receive FDA 510(k) clearance?

Valkyrie Thoracic Fixation System received FDA 510(k) clearance on 2023-12-08, under 510(k) number K232515.

Who is the listed applicant for Valkyrie Thoracic Fixation System?

The FDA 510(k) record lists Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Valkyrie Thoracic Fixation System?

The FDA product code for Valkyrie Thoracic Fixation System is HRS.

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Outros registros que listam Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices como candidato(a)

K211695Valkyrie Thoracic Fixation System K202889Sistema de Fixação Torácica Valkyrie da Able Medical Devices

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Fonte oficial

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