FDA 510(k)

Ortho Aligner System

Numéro K : K212496 · 2021-11-04

Date de décision2021-11-04

Code produitNXC

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

Ortho Aligner System is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Lab Services, LLC. It received FDA 510(k) clearance on 2021-11-04 under 510(k) number K212496. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Ortho Aligner System?

Ortho Aligner System is a medical device that received FDA 510(k) clearance on 2021-11-04. The listed applicant is Ortho Lab Services, LLC. The 510(k) number is K212496.

When did Ortho Aligner System receive FDA 510(k) clearance?

Ortho Aligner System received FDA 510(k) clearance on 2021-11-04, under 510(k) number K212496.

Who is the listed applicant for Ortho Aligner System?

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

What is the FDA product code for Ortho Aligner System?

The FDA product code for Ortho Aligner System is NXC.

Essais cliniques associés

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Dispositifs connexes (Code : NXC)

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Source officielle

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