Nano FortiFix® System— 510(k) K203452

Substantially Equivalent

Nanovis, LLC

FDA 510(k) clearance K203452 for Nano FortiFix® System, Substantially Equivalent on 2020-12-22. Applicant: Nanovis, LLC.

Clearance details

Applicant: Nanovis, LLC
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2020-11-23
Decision date: 2020-12-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Columbia City, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.