Clearance Summary
CarboClear Cervical Cage System, CarboClear Cervical VBR System received FDA 510(k) clearance under submission number K222874, sponsored by Carbofix Orthpedics , 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 2023-07-26.
- Submission: K222874
- Applicant / Sponsor: Carbofix Orthpedics , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2023-07-26
Classification & Regulation
This clearance is catalogued under FDA product code ODP and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.