Clearance Summary
CarboClear Navigated Instruments received FDA 510(k) clearance under submission number K201251, sponsored by CarboFix Orthopedics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2020-08-05.
- Submission: K201251
- Applicant / Sponsor: CarboFix Orthopedics , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2020-08-05
Classification & Regulation
This clearance is catalogued under FDA product code OLO and 21 CFR 882.4560, within the Neurology review panel as a Class II device.