Clearance Summary
High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws received FDA 510(k) clearance under submission number K190526, sponsored by CarboFix Orthopedics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2019-09-19.
- Submission: K190526
- Applicant / Sponsor: CarboFix Orthopedics , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3027
- Decision date: 2019-09-19
Classification & Regulation
This clearance is catalogued under FDA product code PML and 21 CFR 888.3027, within the Orthopedic review panel as a Class II device.