K234116
- 510(k) number
- K234116
- Device name
- Trigon Trigon HA Stand-Alone Wedge Fixation System
- Applicant
- Nvision Biomedical Technologies TX · US
- Product code
- PLF — Bone Wedge
- Decision date
- 2024-01-26
- Date received
- 2023-12-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K234116.pdf
Official FDA record: K234116
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.