510(k) K161993— Leva® Anterior Interbody System

Substantially Equivalent

Spine Wave, Inc.

Clearance details

Applicant: Spine Wave, Inc.
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2016-07-19
Decision date: 2016-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shelton, CT, 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.