Clearance Summary
CC-Clip® Implant System received FDA 510(k) clearance under submission number K232780, sponsored by Cc-Instruments, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2023-12-18.
- Submission: K232780
- Applicant / Sponsor: Cc-Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2023-12-18
Classification & Regulation
This clearance is catalogued under FDA product code HTN and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.