510(k) K201961
K201961 is an FDA 510(k) premarket notification submitted by Illuminoss Medical, Inc. for the device "IlluminOss Photodynamic Bone Stabilization System". The FDA issued a decision of Substantially Equivalent on August 13, 2020. 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. Illuminoss Medical, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 2020
- Date Received
- July 14, 2020
- Clearance Type
- Special
- 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.