K230891
- 510(k) number
- K230891
- Device name
- SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant
- Applicant
- Healthium Medtech Limited IN
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2023-12-28
- Date received
- 2023-03-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K230891.pdf
Official FDA record: K230891
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.