510(k) K253545
- Device
- Vulcan Spinal System
- Applicant
- K2m, Inc.
- 510(k) number
- K253545
- Product code
- NKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-02-10
- Date received
- 2025-11-14
- Regulation
- 888.3070
- Classification name
- Thoracolumbosacral Pedicle Screw System
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Tee Pamon
- Address
- 600 Hope Pkwy. SE Leesburg VA US 20175 20175
FDA Registration Numbers
- 1450662
- 3021006165
- 3010128826
- 3015487912
- 3014252644
- 3001239363
- 3004464325
- 2183744
- 3023852420
- 1834331
- 3003541440
- 3013756169
- 3013194153
- 3009962553
- 1833824
- 3009504230
- 3000170817
- 1319660
- 3008754074
- 3014268622
- 3021945817
- 3007700286
- 1045254
- 3012429289
- 9612277
- 3010863450
- 3019767615
- 1531050
- 3006128100
- 3019837678
- 1225838
- 1030489
- 3029933740
- 3004719693
- 1649379
- 2183449
- 3039169546
- 3004024955
- 9617616
- 3012120772
- 3010365473
- 3005083075
- 3009887475
- 3022518322
- 3023138345
- 1221053
- 3010047454
- 3013546462
- 9615014
- 3009973505
- 3009554293
- 2087234
- 2032112
- 3012447612
- 3012599928
- 9616062
- 9611827
- 3011513267
- 1530390
- 2531195
- 3006017180
- 1835296
- 3007887127
- 2029275
- 9615128
- 3004049923
- 3008992889
- 3010531060
- 3004893332
- 3009988302
- 1528646
- 1722511
- 3011181154
- 3005226664
- 3016084569
- 3009165919
- 3011277306
- 3003526896
- 3019356409
- 8010468
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code NKB
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260989 | Varion Thoracolumbar Fixation System | Kyocera Medical Technologies Inc. (KMTI) | 2026-05-15 |
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System | Globus Medical, Inc. | 2026-05-07 |
| K261130 | AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | 2026-05-05 |
| K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA | 2026-05-01 |
| K252542 | LEO Spinal System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-29 |
| K253940 | M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. | 2026-04-28 |
| K260216 | CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System | Medtronic Sofamor Danek USA, Inc. | 2026-04-21 |
| K254274 | ARx® SAI Implant System | Life Spine, Inc. | 2026-04-16 |
| K260786 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026-04-03 |
| K254247 | OSTEOMNI SPINAL FIXATION SYSTEM | Osteomni, Inc. | 2026-02-24 |
| K253169 | Duet Spinal Fixation System | Box Spine, LLC | 2026-02-23 |
| K252461 | Swedge Pedicle Screw Fixation System Bezier Rod | Spinal Resources, Inc. | 2026-01-13 |
| K253990 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026-01-07 |
| K253941 | CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly) | Medtronic Sofamor Danek USA, Inc. | 2026-01-07 |
| K253721 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2025-12-17 |