LANX FUSION SYSTEM— 510(k) K131547

Substantially Equivalent

Lanx, Inc.

FDA 510(k) clearance K131547 for LANX FUSION SYSTEM, Substantially Equivalent on 2013-07-12. Applicant: Lanx, Inc..

Clearance details

Applicant: Lanx, Inc.
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2013-05-29
Decision date: 2013-07-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Broomfield, CO, US

Download summary PDF View on FDA.gov ↗

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.