510(k) K231404
T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button by
Healthium Medtech Limited
— Product Code MBI
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 2023
- Date Received
- May 15, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Fixation, Nondegradable, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type