FDA 510(k)

Seneka II Polyscrew Pedicle Fixation System

Número K: K153525 · 2016-01-28

Data da decisão2016-01-28

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Seneka II Polyscrew Pedicle Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Senecka Spine. It received FDA 510(k) clearance on 2016-01-28 under 510(k) number K153525. 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 Seneka II Polyscrew Pedicle Fixation System?

Seneka II Polyscrew Pedicle Fixation System is a medical device that received FDA 510(k) clearance on 2016-01-28. The listed applicant is Senecka Spine. The 510(k) number is K153525.

When did Seneka II Polyscrew Pedicle Fixation System receive FDA 510(k) clearance?

Seneka II Polyscrew Pedicle Fixation System received FDA 510(k) clearance on 2016-01-28, under 510(k) number K153525.

Who is the listed applicant for Seneka II Polyscrew Pedicle Fixation System?

The FDA 510(k) record lists Senecka Spine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Seneka II Polyscrew Pedicle Fixation System?

The FDA product code for Seneka II Polyscrew Pedicle Fixation System is NKB.

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