Ortho Aligner System
K-Number: K212496 · 2021-11-04
ApplicantOrtho Lab Services, LLC
Decision Date2021-11-04
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Ortho Aligner System is a medical device manufactured by Ortho Lab Services, LLC. It received FDA 510(k) clearance on 2021-11-04 under approval number K212496. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ortho Aligner System?
Ortho Aligner System is a medical device that received FDA 510(k) clearance on 2021-11-04. It is manufactured by Ortho Lab Services, LLC. The 510(k) number is K212496.
When was Ortho Aligner System approved by the FDA?
Ortho Aligner System received FDA 510(k) clearance on 2021-11-04, under approval number K212496.
What company makes Ortho Aligner System?
Ortho Aligner System is manufactured by Ortho Lab Services, LLC.
What is the FDA product code for Ortho Aligner System?
The FDA product code for Ortho Aligner System is NXC.
Related Clinical Trials
Related Devices (Code: NXC)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.