FDA 510(k)

Sistema Espinal ArcadiusXP C

Número K: K153629 · 2016-05-25

RequerenteAesculap Implant Systems, Inc.

Data da decisão2016-05-25

Código do produtoOVE

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ArcadiusXP C Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implant Systems, Inc.. It received FDA 510(k) clearance on 2016-05-25 under 510(k) number K153629. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ArcadiusXP C Spinal System?

ArcadiusXP C Spinal System is a medical device that received FDA 510(k) clearance on 2016-05-25. The listed applicant is Aesculap Implant Systems, Inc.. The 510(k) number is K153629.

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

ArcadiusXP C Spinal System received FDA 510(k) clearance on 2016-05-25, under 510(k) number K153629.

Who is the listed applicant for ArcadiusXP C Spinal System?

The FDA 510(k) record lists Aesculap Implant Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ArcadiusXP C Spinal System?

The FDA product code for ArcadiusXP C Spinal System is OVE.

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