NanoOrtho NanoKnee® System— 510(k) K190633

Substantially Equivalent

Nanoortho, LLC

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

Clearance details

Applicant: Nanoortho, LLC
Product code: Code HRY
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 ↗

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.