Clearance Summary
APTUS Hand System; APTUS Elbow Dorsal Olecranon received FDA 510(k) clearance under submission number K243610, sponsored by Medartis AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2025-03-07.
- Submission: K243610
- Applicant / Sponsor: Medartis AG
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2025-03-07
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.