Clearance Summary
VersaTap, VersaLat, DueLock, VersaTi, MiniTi received FDA 510(k) clearance under submission number K212381, sponsored by Ortho-Design (Pty), Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2021-12-06.
- Submission: K212381
- Applicant / Sponsor: Ortho-Design (Pty), Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2021-12-06
Classification & Regulation
This clearance is catalogued under FDA product code MBI and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.