FDA 510(k)

CRESCENT™ Spinal System

Número K: K171031 · 2017-07-06

Data da decisão2017-07-06

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

CRESCENT™ Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2017-07-06 under 510(k) number K171031. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CRESCENT™ Spinal System?

CRESCENT™ Spinal System is a medical device that received FDA 510(k) clearance on 2017-07-06. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K171031.

When did CRESCENT™ Spinal System receive FDA 510(k) clearance?

CRESCENT™ Spinal System received FDA 510(k) clearance on 2017-07-06, under 510(k) number K171031.

Who is the listed applicant for CRESCENT™ Spinal System?

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

What is the FDA product code for CRESCENT™ Spinal System?

The FDA product code for CRESCENT™ Spinal System is MAX.

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Dispositivos Relacionados (Código: MAX)

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Fonte oficial

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