K253545
- 510(k) number
- K253545
- Device name
- Vulcan Spinal System
- Applicant
- K2m, Inc. VA · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2026-02-10
- Date received
- 2025-11-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K253545.pdf
Official FDA record: K253545
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.