Clearance Summary
ONE Planner Hip received FDA 510(k) clearance under submission number K210653, sponsored by Orthosoft D/B/A Zimmer Cas. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2021-07-07.
- Submission: K210653
- Applicant / Sponsor: Orthosoft D/B/A Zimmer Cas
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2021-07-07
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.