FDA 510(k)

FUSE Spinal System

Número K: K171468 · 2017-06-13

Data da decisão2017-06-13

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

FUSE 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 2017-06-13 under 510(k) number K171468. 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 FUSE Spinal System?

FUSE Spinal System is a medical device that received FDA 510(k) clearance on 2017-06-13. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K171468.

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

FUSE Spinal System received FDA 510(k) clearance on 2017-06-13, under 510(k) number K171468.

Who is the listed applicant for FUSE 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 FUSE Spinal System?

The FDA product code for FUSE Spinal System is MAX.

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Fonte oficial

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