NanoOrtho NanoKnee® System— 510(k) K190633

Name: FDA 510(k) clearance K190633
Creator: U.S. Food and Drug Administration
Published: 2019-12-20

Substantially Equivalent

Nanoortho, LLC

FDA 510(k) clearance K190633 for NanoOrtho NanoKnee® System, Substantially Equivalent on 2019-12-20. Applicant: Nanoortho, LLC. Device class: 2.

Clearance details

Applicant: Nanoortho, LLC
Product code: Code HRY
Device class: Class 2
Regulation: 21 CFR 888.3530
Advisory panel: Orthopedic
Date received: 2019-03-12
Decision date: 2019-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arroyo Grande, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRY

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K193549 — SIGMA High Performance (HP) Partial Knee System2020-04-16
K152631 — MPO Total Knee Systems MR Labeling2016-03-23
K150410 — RESTORIS POROUS PARTIAL KNEE SYSTEM2015-03-20
K133940 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)2014-03-28
K131167 — UNIVATION2013-10-17

Adverse events under product code HRY

product code HRY

Injury: 1,551
Malfunction: 2,753
Total: 4,304

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.