IlluminOss Bone Stabilization System— 510(k) K181228

Name: FDA 510(k) clearance K181228
Creator: U.S. Food and Drug Administration
Published: 2018-08-31

Substantially Equivalent

Illuminoss Medical, Inc.

FDA 510(k) clearance K181228 for IlluminOss Bone Stabilization System, Substantially Equivalent on 2018-08-31. Applicant: Illuminoss Medical, Inc.. Device class: 2.

Clearance details

Applicant: Illuminoss Medical, Inc.
Product code: Code QAD
Device class: Class 2
Regulation: 21 CFR 888.3023
Advisory panel: Orthopedic
Date received: 2018-05-08
Decision date: 2018-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Providence, RI, US

Download summary PDF View on FDA.gov ↗

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K183145 — IlluminOss Photodynamic Bone Stabilization System2018-12-13

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.