K160874

Substantially Equivalent

Nanovis Intervertebral Body Fusion System and FortiCore®

Applicant: Nanovis, LLC
Product code: MAX
Advisory panel: Orthopedic
Date received: 2016-03-30
Decision date: 2016-06-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Columbia City, IN, US

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.