Vulcan Spinal System— 510(k) K253545
Substantially EquivalentK2m, Inc.
FDA 510(k) clearance K253545 for Vulcan Spinal System, Substantially Equivalent on 2026-02-10. Applicant: K2m, Inc.. Device class: 2.
Summary
K2m's Vulcan Spinal System is filed under product code NKB, thoracolumbosacral pedicle screw system. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 888.3070. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).
K2m filed from Leesburg, Virginia. FDA found it substantially equivalent 88 calendar days after receipt (November 14, 2025 to February 10, 2026).
Clearance details
- Applicant
- K2m, Inc.
- Product code
- Product code NKB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leesburg, VA, US
Recent devices under product code NKB
view allMore clearances from K2m, Inc.
view allAdverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
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.