FDA 510(k)

OLYMPIC Posterior Spinal Fixation System

Número K: K153446 · 2016-04-08

Data da decisão2016-04-08

Código do produtoOSH

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. It received FDA 510(k) clearance on 2016-04-08 under 510(k) number K153446. The device is classified under product code OSH. 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 2016-04-08. The listed applicant is Astura Medical. The 510(k) number is K153446.

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

OLYMPIC Posterior Spinal Fixation System received FDA 510(k) clearance on 2016-04-08, under 510(k) number K153446.

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

The FDA 510(k) record lists Astura Medical 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 OSH.

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Outros registros que listam Astura Medical como candidato(a)

K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System K243259MASADA Modular Spinal Fixation System K240160EGPS Navigated Instruments K233359DOMINION Expandable Corpectomy System K231694MASADA Modular Spinal Fixation System

Ver todos os 21 dispositivos →

Fonte oficial

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