FDA 510(k)

Modulift Vertebral Body Replacement (VBR) System

Número K: K172032 · 2017-11-20

RequerenteAesculap Implants Systems, Inc.

Data da decisão2017-11-20

Código do produtoPLR

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Modulift Vertebral Body Replacement (VBR) System is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implants Systems, Inc.. It received FDA 510(k) clearance on 2017-11-20 under 510(k) number K172032. The device is classified under product code PLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Modulift Vertebral Body Replacement (VBR) System?

Modulift Vertebral Body Replacement (VBR) System is a medical device that received FDA 510(k) clearance on 2017-11-20. The listed applicant is Aesculap Implants Systems, Inc.. The 510(k) number is K172032.

When did Modulift Vertebral Body Replacement (VBR) System receive FDA 510(k) clearance?

Modulift Vertebral Body Replacement (VBR) System received FDA 510(k) clearance on 2017-11-20, under 510(k) number K172032.

Who is the listed applicant for Modulift Vertebral Body Replacement (VBR) System?

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

What is the FDA product code for Modulift Vertebral Body Replacement (VBR) System?

The FDA product code for Modulift Vertebral Body Replacement (VBR) System is PLR.

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