510(k) DEN160062

IlluminOss Bone Stabilization System by Illminoss Medical, Inc. — Product Code QAD

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: December 19, 2017
Date Received: December 28, 2016
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
Device Class: Class II
Regulation Number: 888.3023
Review Panel: OR
Submission Type

Is a device intended to be implanted that consists of a polymeric balloon that is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures. The balloon is infused with a liquid monomer that causes the balloon to fill the medullary canal of the fractured bone. The device is then exposed to a light source that polymerizes the light-activated monomer within the balloon creating a hardened rigid structure.

Other clearances for product code QAD

K233436 — IlluminOss Photodynamic Bone Stabilization System (January 19, 2024)
K202887 — IlluminOss Bone Stabilization System (October 27, 2020)
K201961 — IlluminOss Photodynamic Bone Stabilization System (August 13, 2020)
K200295 — IlluminOss Bone Stabilization System (June 25, 2020)
K183145 — IlluminOss Photodynamic Bone Stabilization System (December 13, 2018)
K181228 — IlluminOss Bone Stabilization System (August 31, 2018)