Clearance Summary
CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System received FDA 510(k) clearance under submission number K201926, sponsored by CarboFix Orthopedics , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2020-08-07.
- Submission: K201926
- Applicant / Sponsor: CarboFix Orthopedics , Ltd.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2020-08-07
Classification & Regulation
This clearance is catalogued under FDA product code NKB and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.