Clearance Summary
IlluminOss Bone Stabilization System received FDA 510(k) clearance under submission number DEN160062, sponsored by Illminoss Medical, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2017-12-19.
- Submission: DEN160062
- Applicant / Sponsor: Illminoss Medical, Inc.
- Clearance pathway: Direct
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3023
- Decision date: 2017-12-19
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.