OrthAlign Plus System
K-Number: K200642 · 2020-04-10
ApplicantOrthalign, Inc.
Decision Date2020-04-10
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
OrthAlign Plus System is a medical device manufactured by Orthalign, Inc.. It received FDA 510(k) clearance on 2020-04-10 under approval number K200642. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OrthAlign Plus System?
OrthAlign Plus System is a medical device that received FDA 510(k) clearance on 2020-04-10. It is manufactured by Orthalign, Inc.. The 510(k) number is K200642.
When was OrthAlign Plus System approved by the FDA?
OrthAlign Plus System received FDA 510(k) clearance on 2020-04-10, under approval number K200642.
What company makes OrthAlign Plus System?
OrthAlign Plus System is manufactured by Orthalign, Inc..
What is the FDA product code for OrthAlign Plus System?
The FDA product code for OrthAlign Plus System is OLO.
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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.