FDA 510(k)

Biomet Spine Fusion System

Número K: K153695 · 2016-01-21

Data da decisão2016-01-21

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Biomet Spine Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Spine, LLC. It received FDA 510(k) clearance on 2016-01-21 under 510(k) number K153695. 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 Biomet Spine Fusion System?

Biomet Spine Fusion System is a medical device that received FDA 510(k) clearance on 2016-01-21. The listed applicant is Biomet Spine, LLC. The 510(k) number is K153695.

When did Biomet Spine Fusion System receive FDA 510(k) clearance?

Biomet Spine Fusion System received FDA 510(k) clearance on 2016-01-21, under 510(k) number K153695.

Who is the listed applicant for Biomet Spine Fusion System?

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

What is the FDA product code for Biomet Spine Fusion System?

The FDA product code for Biomet Spine Fusion System is MAX.

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