FDA 510(k)

Lucent XP, Lucent XP Curved

Número K: K202298 · 2020-12-22

Data da decisão2020-12-22

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Lucent XP, Lucent XP Curved 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 2020-12-22 under 510(k) number K202298. 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 XP, Lucent XP Curved?

Lucent XP, Lucent XP Curved is a medical device that received FDA 510(k) clearance on 2020-12-22. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K202298.

When did Lucent XP, Lucent XP Curved receive FDA 510(k) clearance?

Lucent XP, Lucent XP Curved received FDA 510(k) clearance on 2020-12-22, under 510(k) number K202298.

Who is the listed applicant for Lucent XP, Lucent XP Curved?

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 XP, Lucent XP Curved?

The FDA product code for Lucent XP, Lucent XP Curved is MAX.

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Fonte oficial

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