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 the device name listed in this FDA 510(k) record. The listed applicant is Nanoortho, LLC. It received FDA 510(k) clearance on 2019-12-20 under 510(k) 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. The listed applicant is Nanoortho, LLC. The 510(k) number is K190633.

When did NanoOrtho NanoKnee® System receive FDA 510(k) clearance?

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

Who is the listed applicant for NanoOrtho NanoKnee® System?

The FDA 510(k) record lists Nanoortho, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: HRY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UC K152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.