FDA 510(k)

OLYMPIC Posterior Spinal Fixation System

Número K: K182239 · 2018-10-18

Data da decisão2018-10-18

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

OLYMPIC Posterior Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Astura Medical, LLC. It received FDA 510(k) clearance on 2018-10-18 under 510(k) number K182239. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OLYMPIC Posterior Spinal Fixation System?

OLYMPIC Posterior Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2018-10-18. The listed applicant is Astura Medical, LLC. The 510(k) number is K182239.

When did OLYMPIC Posterior Spinal Fixation System receive FDA 510(k) clearance?

OLYMPIC Posterior Spinal Fixation System received FDA 510(k) clearance on 2018-10-18, under 510(k) number K182239.

Who is the listed applicant for OLYMPIC Posterior Spinal Fixation System?

The FDA 510(k) record lists Astura Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPIC Posterior Spinal Fixation System?

The FDA product code for OLYMPIC Posterior Spinal Fixation System is NKB.

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Fonte oficial

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