Clearance Summary
ecoFIX® received FDA 510(k) clearance under submission number K231787, sponsored by Science & Bio Materials (S.B.M.) Sas. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2023-07-26.
- Submission: K231787
- Applicant / Sponsor: Science & Bio Materials (S.B.M.) Sas
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2023-07-26
Classification & Regulation
This clearance is catalogued under FDA product code MAI and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.