FDA 510(k)

SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF

Número K: K153783 · 2016-05-04

Data da decisão2016-05-04

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF is the device name listed in this FDA 510(k) record. The listed applicant is Spinevision S.A.. It received FDA 510(k) clearance on 2016-05-04 under 510(k) number K153783. 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 SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF?

SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF is a medical device that received FDA 510(k) clearance on 2016-05-04. The listed applicant is Spinevision S.A.. The 510(k) number is K153783.

When did SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF receive FDA 510(k) clearance?

SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF received FDA 510(k) clearance on 2016-05-04, under 510(k) number K153783.

Who is the listed applicant for SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF?

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

What is the FDA product code for SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF?

The FDA product code for SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF is MAX.

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Fonte oficial

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