IlluminOss Bone Stabilization System— 510(k) K200295

Substantially Equivalent

Illuminoss Medical, Inc.

FDA 510(k) clearance K200295 for IlluminOss Bone Stabilization System, Substantially Equivalent on 2020-06-25. Applicant: Illuminoss Medical, Inc..

Clearance details

Applicant: Illuminoss Medical, Inc.
Product code: Code QAD
Advisory panel: Orthopedic
Date received: 2020-02-05
Decision date: 2020-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Providence, RI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QAD

product code QAD

Death: 13
Total: 13

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.