Clearance Summary
Mini and Micro Fragments Reconstruction System-NEOFIX received FDA 510(k) clearance under submission number K142419, sponsored by Neoortho Productos Orthopedicos S/A. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2014-12-16.
- Submission: K142419
- Applicant / Sponsor: Neoortho Productos Orthopedicos S/A
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2014-12-16
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.