K243231
- 510(k) number
- K243231
- Device name
- Trigon PEEK HA Wedges
- Applicant
- Nvision Biomedical Technologies TX · US
- Product code
- PLF — Bone Wedge
- Decision date
- 2024-11-08
- Date received
- 2024-10-09
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.6 MB · U.S. public domain
Also available from FDA: K243231.pdf
Official FDA record: K243231
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.