Vortex5 Tailor's Bunion Correction System— 510(k) K260291
Substantially EquivalentNvision Biomedical Technologies, Inc.
FDA 510(k) clearance K260291 for Vortex5 Tailor's Bunion Correction System, Substantially Equivalent on 2026-03-25. Applicant: Nvision Biomedical Technologies, Inc.. Device class: 2.
Summary
Nvision Biomedical Technologies' Vortex5 Tailor's Bunion Correction System is filed under HRS, bone fixation plates. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Nvision Biomedical Technologies filed from San Antonio, Texas. Review took 55 calendar days (January 29 to March 25, 2026).
Clearance details
- Applicant
- Nvision Biomedical Technologies, Inc.
- Product code
- Product code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Antonio, TX, US
Recent devices under product code HRS
view allMore clearances from Nvision Biomedical Technologies, Inc.
view allAdverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.