FDA 510(k)

NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System

Número K: K203129 · 2021-01-12

Data da decisão2021-01-12

Código do produtoOVE

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System is the device name listed in this FDA 510(k) record. The listed applicant is Precision Spine, Inc.. It received FDA 510(k) clearance on 2021-01-12 under 510(k) number K203129. 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 NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System?

NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System is a medical device that received FDA 510(k) clearance on 2021-01-12. The listed applicant is Precision Spine, Inc.. The 510(k) number is K203129.

When did NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System receive FDA 510(k) clearance?

NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System received FDA 510(k) clearance on 2021-01-12, under 510(k) number K203129.

Who is the listed applicant for NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System?

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

What is the FDA product code for NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System?

The FDA product code for NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System is OVE.

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Fonte oficial

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