Clearance Summary
ROSA Hip System received FDA 510(k) clearance under submission number K231162, sponsored by Orthosoft Inc (D/B/A Zimmer Cas). The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2023-05-23.
- Submission: K231162
- Applicant / Sponsor: Orthosoft Inc (D/B/A Zimmer Cas)
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2023-05-23
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.