Clearance Summary
ROSA® Knee System received FDA 510(k) clearance under submission number K221928, sponsored by Orthosoft D/B/A Zimmer Cas. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2022-10-04.
- Submission: K221928
- Applicant / Sponsor: Orthosoft D/B/A Zimmer Cas
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2022-10-04
Classification & Regulation
This clearance is catalogued under FDA product code OLO and 21 CFR 882.4560, within the Neurology review panel as a Class II device.