Clearance Summary
CoLink NeoFuse MIS Plating System (see attached parts list) received FDA 510(k) clearance under submission number K241387, sponsored by In2bones USA. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2024-08-13.
- Submission: K241387
- Applicant / Sponsor: In2bones USA
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2024-08-13
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.