Clearance Summary
BIOCERAM AZUL® HEAD received FDA 510(k) clearance under submission number K243444, sponsored by Kyocera Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2024-12-05.
- Submission: K243444
- Applicant / Sponsor: Kyocera Corporation
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3353
- Decision date: 2024-12-05
Classification & Regulation
This clearance is catalogued under FDA product code LZO and 21 CFR 888.3353, within the Orthopedic review panel as a Class II device.