K232941
- 510(k) number
- K232941
- Device name
- Megaloop Button System
- Applicant
- Suzhou Endophix Co., Ltd. CN
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2024-05-03
- Date received
- 2023-09-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K232941.pdf
Official FDA record: K232941
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.