Clearance Summary
ROSA Knee System received FDA 510(k) clearance under submission number K182964, sponsored by Orthosoft Inc (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 2019-01-24.
- Submission: K182964
- Applicant / Sponsor: Orthosoft Inc (D/B/A Zimmer Cas)
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2019-01-24
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.