Nano FortiCore, FortiCore— 510(k) K191822

Substantially Equivalent

Nanovis, LLC

FDA 510(k) clearance K191822 for Nano FortiCore, FortiCore, Substantially Equivalent on 2019-10-11. Applicant: Nanovis, LLC.

Clearance details

Applicant: Nanovis, LLC
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2019-07-08
Decision date: 2019-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia City, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.