Clearance Summary
SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant received FDA 510(k) clearance under submission number K230891, sponsored by Healthium Medtech Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2023-12-28.
- Submission: K230891
- Applicant / Sponsor: Healthium Medtech Limited
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2023-12-28
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.