IlluminOss Bone Stabilization System— 510(k) K202887

Name: FDA 510(k) clearance K202887
Creator: U.S. Food and Drug Administration
Published: 2020-10-27

Substantially Equivalent

Illuminoss Medical, Inc.

FDA 510(k) clearance K202887 for IlluminOss Bone Stabilization System, Substantially Equivalent on 2020-10-27. 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: 2020-09-28
Decision date: 2020-10-27
Decision: Substantially Equivalent
Clearance type: Special
Location: East Providence, RI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QAD

view all

K233436 — IlluminOss Photodynamic Bone Stabilization System2024-01-19
K201961 — IlluminOss Photodynamic Bone Stabilization System2020-08-13
K200295 — IlluminOss Bone Stabilization System2020-06-25
K183145 — IlluminOss Photodynamic Bone Stabilization System2018-12-13
K181228 — IlluminOss Bone Stabilization System2018-08-31

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.