FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Vulcan Spinal System
K Number: K253545
·
Decision Feb 10, 2026
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
100
Review Days
88
Basic Information
- Device Name
- Vulcan Spinal System
- K Number
- K253545
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- K2m, Inc.
- Date Received
- November 14, 2025
- Decision Date
- February 10, 2026
- Product Code
- NKB
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | FDA class 2 | Orthopedic |
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| K Number | Device Name | ||
|---|---|---|---|
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| K193129 | Yukon OCT Spinal System | Feb 7, 2020 | Substantially Equivalent |
| K192911 | Brainlab Compatible K2M Navigation Instruments | Nov 14, 2019 | Substantially Equivalent |
| K190179 | SAHARA Stabilization System | Oct 3, 2019 | Substantially Equivalent |
| K190584 | CAYMAN LP Plate System | May 15, 2019 | Substantially Equivalent |