Clearance Summary
CarboClear Lumbar Cage System received FDA 510(k) clearance under submission number K193378, 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 2020-03-02.
- Submission: K193378
- Applicant / Sponsor: CarboFix Orthopedics , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2020-03-02
Classification & Regulation
This clearance is catalogued under FDA product code MAX and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.