Clearance Summary
IlluminOss Photodynamic Bone Stabilization System received FDA 510(k) clearance under submission number K201961, sponsored by Illuminoss Medical, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2020-08-13.
- Submission: K201961
- Applicant / Sponsor: Illuminoss Medical, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3023
- Decision date: 2020-08-13
Classification & Regulation
This clearance is catalogued under FDA product code QAD and 21 CFR 888.3023, within the Orthopedic review panel as a Class II device.