QAD — Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated Class II
Classification Details
- Product Code
- QAD
- Device Class
- Class II
- Regulation Number
- 888.3023
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233436 | illuminoss medical | IlluminOss Photodynamic Bone Stabilization System | January 19, 2024 |
| K202887 | illuminoss medical | IlluminOss Bone Stabilization System | October 27, 2020 |
| K201961 | illuminoss medical | IlluminOss Photodynamic Bone Stabilization System | August 13, 2020 |
| K200295 | illuminoss medical | IlluminOss Bone Stabilization System | June 25, 2020 |
| K183145 | illuminoss medical | IlluminOss Photodynamic Bone Stabilization System | December 13, 2018 |
| K181228 | illuminoss medical | IlluminOss Bone Stabilization System | August 31, 2018 |
| DEN160062 | illminoss medical | IlluminOss Bone Stabilization System | December 19, 2017 |