K232886
- 510(k) number
- K232886
- Device name
- INFILOOP® Fixed Loop UHMWPE Suture Titanium Button
- Applicant
- Healthium Medtech Limited IN
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2023-11-08
- Date received
- 2023-09-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K232886.pdf
Official FDA record: K232886
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.