FDA 510(k)

Lucent 3D Spinal System

Número K: K203254 · 2021-03-26

Data da decisão2021-03-26

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Lucent 3D Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Elements, Inc.. It received FDA 510(k) clearance on 2021-03-26 under 510(k) number K203254. 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 Lucent 3D Spinal System?

Lucent 3D Spinal System is a medical device that received FDA 510(k) clearance on 2021-03-26. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K203254.

When did Lucent 3D Spinal System receive FDA 510(k) clearance?

Lucent 3D Spinal System received FDA 510(k) clearance on 2021-03-26, under 510(k) number K203254.

Who is the listed applicant for Lucent 3D Spinal System?

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

What is the FDA product code for Lucent 3D Spinal System?

The FDA product code for Lucent 3D Spinal System is MAX.

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Fonte oficial

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