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FDA 510(k)

NanoOrtho NanoKnee® System

K-Number: K190633 · 2019-12-20

Decision Date2019-12-20
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NanoOrtho NanoKnee® System is a medical device manufactured by Nanoortho, LLC. It received FDA 510(k) clearance on 2019-12-20 under approval number K190633. The device is classified under product code HRY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NanoOrtho NanoKnee® System?

NanoOrtho NanoKnee® System is a medical device that received FDA 510(k) clearance on 2019-12-20. It is manufactured by Nanoortho, LLC. The 510(k) number is K190633.

When was NanoOrtho NanoKnee® System approved by the FDA?

NanoOrtho NanoKnee® System received FDA 510(k) clearance on 2019-12-20, under approval number K190633.

What company makes NanoOrtho NanoKnee® System?

NanoOrtho NanoKnee® System is manufactured by Nanoortho, LLC.

What is the FDA product code for NanoOrtho NanoKnee® System?

The FDA product code for NanoOrtho NanoKnee® System is HRY.

Related Devices (Code: HRY)

Official Source

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