K162236

Substantially Equivalent

Ax Stand-Alone ALIF System

Applicant: Innovasis, Inc.
Product code: OVD
Advisory panel: Orthopedic
Date received: 2016-08-09
Decision date: 2017-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.