Clearance Summary
OptiVu ROSA® MxR received FDA 510(k) clearance under submission number K230567, 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 2023-06-13.
- Submission: K230567
- 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: 2023-06-13
Classification & Regulation
This clearance is catalogued under FDA product code SBF and 21 CFR 882.4560, within the Neurology review panel as a Class II device.