FDA 510(k)

Vitality® Spinal Fixation System, Vitality®+ Power Instrument System

Número K: K172275 · 2017-09-27

Data da decisão2017-09-27

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vitality® Spinal Fixation System, Vitality®+ Power Instrument System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Biomet Spine, Inc.. It received FDA 510(k) clearance on 2017-09-27 under 510(k) number K172275. 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 Vitality® Spinal Fixation System, Vitality®+ Power Instrument System?

Vitality® Spinal Fixation System, Vitality®+ Power Instrument System is a medical device that received FDA 510(k) clearance on 2017-09-27. The listed applicant is Zimmer Biomet Spine, Inc.. The 510(k) number is K172275.

When did Vitality® Spinal Fixation System, Vitality®+ Power Instrument System receive FDA 510(k) clearance?

Vitality® Spinal Fixation System, Vitality®+ Power Instrument System received FDA 510(k) clearance on 2017-09-27, under 510(k) number K172275.

Who is the listed applicant for Vitality® Spinal Fixation System, Vitality®+ Power Instrument System?

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

What is the FDA product code for Vitality® Spinal Fixation System, Vitality®+ Power Instrument System?

The FDA product code for Vitality® Spinal Fixation System, Vitality®+ Power Instrument System is NKB.

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Fonte oficial

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