K260291
- 510(k) number
- K260291
- Device name
- Vortex5 Tailor's Bunion Correction System
- Applicant
- Nvision Biomedical Technologies, Inc. TX · US
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2026-03-25
- Date received
- 2026-01-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 4.4 MB · U.S. public domain
Also available from FDA: K260291.pdf
Official FDA record: K260291
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.