510(k) K253721
- Device
- KHEIRON® Spinal Fixation System, including patient specific K-ROD
- Applicant
- S.M.A.I.O
- 510(k) number
- K253721
- Product code
- NKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-17
- Date received
- 2025-11-24
- Regulation
- 888.3070
- Classification name
- Thoracolumbosacral Pedicle Screw System
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jean-Charles Roussouly
- Address
- 2 Pl. Berthe Morisot Saint-Priest FR 69800 69800
FDA Registration Numbers#
- 2183946
- 3010440433
- 3025603301
- 9611274
- 1000200989
- 3015383864
- 1000577893
- 3010365473
- 9615766
- 3012711663
- 1047843
- 3011500362
- 1833506
- 3011489618
- 3010370554
- 9617297
- 3012491394
- 3004024955
- 1223434
- 3016084569
- 3022159082
- 9610612
- 1835831
- 3014252644
- 3012381896
- 3006639944
- 1000517406
- 3040335671
- 3005076207
- 3031261833
- 3009380063
- 1319660
- 3013422236
- 3014003062
- 3013514648
- 3006791286
- 3007353762
- 3013546462
- 1000432246
- 3010047454
- 2028632
- 3007923096
- 3006513362
- 3014725904
- 3010143171
- 3004188066
- 3011015572
- 1833824
- 3036756245
- 1226544
- 3003477135
- 2032098
- 3009050824
- 2133687
- 1528646
- 3010329663
- 2648666
- 3016496998
- 3005819474
- 3007922509
- 3011221483
- 9611610
- 3011964577
- 3019767615
- 3013846070
- 3004049923
- 3039169546
- 3021948057
- 3003525643
- 3008455034
- 3022518322
- 3005596514
- 3012131184
- 1000461041
- 2032112
- 9611390
- 3007728266
- 3008992889
- 1835572
Source Documents#
Other 510(k) Records For Product Code NKB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253802 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026-07-01 |
| K253045 | “Socko” Vimax Spinal Fixation System | Socko Medical Co., Ltd. | 2026-06-17 |
| K251251 | ChanPin Pedicle Screw Spinal System | Chanpin Medtak Co., Ltd. | 2026-06-09 |
| 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 |
| K253545 | Vulcan Spinal System | K2m, Inc. | 2026-02-10 |