FDA 510(k)

Sistema de Parafuso Pedicular Monaco da Coluna Spinal Altus

Número K: K230766 · 2023-04-19

Data da decisão2023-04-19

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Altus Spine Monaco Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Altus Spine. It received FDA 510(k) clearance on 2023-04-19 under 510(k) number K230766. 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 Altus Spine Monaco Pedicle Screw System?

Altus Spine Monaco Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2023-04-19. The listed applicant is Altus Spine. The 510(k) number is K230766.

When did Altus Spine Monaco Pedicle Screw System receive FDA 510(k) clearance?

Altus Spine Monaco Pedicle Screw System received FDA 510(k) clearance on 2023-04-19, under 510(k) number K230766.

Who is the listed applicant for Altus Spine Monaco Pedicle Screw System?

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

What is the FDA product code for Altus Spine Monaco Pedicle Screw System?

The FDA product code for Altus Spine Monaco Pedicle Screw System is NKB.

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Dispositivos Relacionados (Código: NKB)

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Fonte oficial

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