OSW Aligner System
K-Number: K191990 · 2019-08-23
ApplicantOsw Manufacturing, LLC
Decision Date2019-08-23
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
OSW Aligner System is a medical device manufactured by Osw Manufacturing, LLC. It received FDA 510(k) clearance on 2019-08-23 under approval number K191990. 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 OSW Aligner System?
OSW Aligner System is a medical device that received FDA 510(k) clearance on 2019-08-23. It is manufactured by Osw Manufacturing, LLC. The 510(k) number is K191990.
When was OSW Aligner System approved by the FDA?
OSW Aligner System received FDA 510(k) clearance on 2019-08-23, under approval number K191990.
What company makes OSW Aligner System?
OSW Aligner System is manufactured by Osw Manufacturing, LLC.
What is the FDA product code for OSW Aligner System?
The FDA product code for OSW 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.