KneeAlign 2 System
K-Number: K163379 · 2017-03-02
ApplicantOrthalign, Inc.
Decision Date2017-03-02
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
KneeAlign 2 System is a medical device manufactured by Orthalign, Inc.. It received FDA 510(k) clearance on 2017-03-02 under approval number K163379. 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 KneeAlign 2 System?
KneeAlign 2 System is a medical device that received FDA 510(k) clearance on 2017-03-02. It is manufactured by Orthalign, Inc.. The 510(k) number is K163379.
When was KneeAlign 2 System approved by the FDA?
KneeAlign 2 System received FDA 510(k) clearance on 2017-03-02, under approval number K163379.
What company makes KneeAlign 2 System?
KneeAlign 2 System is manufactured by Orthalign, Inc..
What is the FDA product code for KneeAlign 2 System?
The FDA product code for KneeAlign 2 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.