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510(k) K233436

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2024
Date Received
October 13, 2023
Clearance Type
Traditional
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 by Illuminoss Medical, Inc.

  • 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)

Other clearances for product code QAD

  • 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)
  • DEN160062 — IlluminOss Bone Stabilization System (December 19, 2017)