Clearance Summary
Zimmer Biomet Ceramic Heads (22.2mm diameter) received FDA 510(k) clearance under submission number K250834, sponsored by Zimmer Biomet. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2025-04-18.
- Submission: K250834
- Applicant / Sponsor: Zimmer Biomet
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3353
- Decision date: 2025-04-18
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.