510(k) K123767— LANX FUSION SYSTEM- SA

Substantially Equivalent

Lanx, Inc.

Clearance details

Applicant: Lanx, Inc.
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2012-12-07
Decision date: 2013-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broomfield, CO, 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.