510(k) DEN160062
DEN160062 is an FDA 510(k) premarket notification submitted by Illminoss Medical, Inc. for the device "IlluminOss Bone Stabilization System". The FDA issued a decision of De Novo Granted on December 19, 2017. The device falls under product code QAD (Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated), a Class II device regulated under 21 CFR 888.3023.
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.