FDA 510(k)

Lucent® XP

Numéro K : K234150 · 2024-03-27

Date de décision2024-03-27

Code produitMAX

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Lucent® XP is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Elements. It received FDA 510(k) clearance on 2024-03-27 under 510(k) number K234150. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Lucent® XP?

Lucent® XP is a medical device that received FDA 510(k) clearance on 2024-03-27. The listed applicant is Spinal Elements. The 510(k) number is K234150.

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

Lucent® XP received FDA 510(k) clearance on 2024-03-27, under 510(k) number K234150.

Who is the listed applicant for Lucent® XP?

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

What is the FDA product code for Lucent® XP?

The FDA product code for Lucent® XP is MAX.

Essais cliniques associés

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Source officielle

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