510(k) K253335
- Device
- CD Horizon? Spinal System
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- 510(k) number
- K253335
- Product code
- NKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-10-24
- Date received
- 2025-09-30
- 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
- Wafa Mustafa
- Address
- 1800 Pyramid Pl. Memphis TN US 38132 38132
FDA Registration Numbers#
- 3012770122
- 3004142400
- 3016050940
- 9617544
- 3005677016
- 1531174
- 3001239363
- 3008868758
- 3015869121
- 1221763
- 3010509633
- 3019356409
- 3014763043
- 9611813
- 1423662
- 3010009693
- 3003541440
- 3014252644
- 3009882675
- 3009106092
- 3003526896
- 3011513267
- 3009381600
- 2244478
- 3009504230
- 3030655570
- 1000517406
- 3013055499
- 2133687
- 8010944
- 3029933740
- 3007728266
- 3011390763
- 2032093
- 3014273424
- 1056553
- 3012764194
- 3010370554
- 3013111980
- 3005596514
- 9615014
- 3031240334
- 3006563559
- 1223434
- 3017036472
- 3009973699
- 3004049923
- 9611610
- 2183744
- 3010363503
- 3015941638
- 3017435639
- 3005083075
- 2031966
- 1424434
- 1528646
- 1530390
- 1649379
- 3007997036
- 3014655115
- 3021945817
- 3002808145
- 1000493591
- 3011874600
- 3015399803
- 1834331
- 3003761012
- 1225838
- 3011489618
- 3007539489
- 3014257776
- 3003855635
- 2531195
- 1835572
- 3014725904
- 3012994232
- 1529009
- 3009973505
- 9681465
Source Documents#
Other 510(k) Records For Product Code NKB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System | Alphatec Spine, Inc. | 2026-07-14 |
| 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 |