FDA 510(k)

CancelleX Porous Titanium Lumbar Interbody Device

Número K: K180373 · 2018-08-24

Data da decisão2018-08-24

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

CancelleX Porous Titanium Lumbar Interbody Device is the device name listed in this FDA 510(k) record. The listed applicant is Xenco Medical, LLC. It received FDA 510(k) clearance on 2018-08-24 under 510(k) number K180373. 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 CancelleX Porous Titanium Lumbar Interbody Device?

CancelleX Porous Titanium Lumbar Interbody Device is a medical device that received FDA 510(k) clearance on 2018-08-24. The listed applicant is Xenco Medical, LLC. The 510(k) number is K180373.

When did CancelleX Porous Titanium Lumbar Interbody Device receive FDA 510(k) clearance?

CancelleX Porous Titanium Lumbar Interbody Device received FDA 510(k) clearance on 2018-08-24, under 510(k) number K180373.

Who is the listed applicant for CancelleX Porous Titanium Lumbar Interbody Device?

The FDA 510(k) record lists Xenco Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CancelleX Porous Titanium Lumbar Interbody Device?

The FDA product code for CancelleX Porous Titanium Lumbar Interbody Device is MAX.

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Outros registros que listam Xenco Medical, LLC como candidato(a)

K243673Xenco Medical CancelleX Cervical Interbody System K223059Xenco Medical InterAlign Cervical Interbody System K213456Xenco Medical Multilevel CerviKit K191074Sorrento Bone Graft Substitute K190364CancelleX Porous Titanium Lumbar Interbody Device K173933Sorrento Bioglass Bone Graft Substitute

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Dispositivos Relacionados (Código: MAX)

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Fonte oficial

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