Healthium Medtech Limited
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 5
- Inspections
- 3
- Compliance Actions
- 1
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K231033 | CEPTRE® Knotted UHMWPE Suture PEEK Anchor | January 4, 2024 |
| K230891 | SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant | December 28, 2023 |
| K232886 | INFILOOP® Fixed Loop UHMWPE Suture Titanium Button | November 8, 2023 |
| K231404 | T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHM | August 4, 2023 |
| K223889 | Stativ® Knotted UHMWPE Suture Anchor | March 22, 2023 |