FDA 510(k)

OneLIF Intervertebral Body Replacement System

Número K: K211769 · 2021-09-07

Data da decisão2021-09-07

Código do produtoOVD

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

OneLIF Intervertebral Body Replacement System is the device name listed in this FDA 510(k) record. The listed applicant is Novapproach Spine. It received FDA 510(k) clearance on 2021-09-07 under 510(k) number K211769. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OneLIF Intervertebral Body Replacement System?

OneLIF Intervertebral Body Replacement System is a medical device that received FDA 510(k) clearance on 2021-09-07. The listed applicant is Novapproach Spine. The 510(k) number is K211769.

When did OneLIF Intervertebral Body Replacement System receive FDA 510(k) clearance?

OneLIF Intervertebral Body Replacement System received FDA 510(k) clearance on 2021-09-07, under 510(k) number K211769.

Who is the listed applicant for OneLIF Intervertebral Body Replacement System?

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

What is the FDA product code for OneLIF Intervertebral Body Replacement System?

The FDA product code for OneLIF Intervertebral Body Replacement System is OVD.

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