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#
- 3014937101
- 3009051471
- 3004499989
- 3010197239
- 1526534
- 3010197224
- 9681465
- 3005641619
- 3010120339
- 2183449
- 9611390
- 2032093
- 3004635447
- 2532027
- 3008114965
- 9610726
- 3010160527
- 3012429289
- 3005827567
- 3004941535
- 3010866843
- 3010175289
- 3017528621
- 3011656326
- 9617297
- 2530808
- 3019837678
- 3010329663
- 9611610
- 3011301313
- 3011181154
- 3013011598
- 3010303097
- 3009380093
- 1828288
- 3029933740
- 3006513362
- 3010123206
- 3009882462
- 3009144915
- 3004142400
- 3016084569
- 3023852420
- 3010120148
- 1030489
- 3009971621
- 3019356409
- 3010041993
- 3017565094
- 9615766
- 3010365473
- 1319660
- 3009173317
- 3009887475
- 3006563559
- 3010120104
- 3023138345
- 3009631939
- 3006846753
- 3009959868
- 1043653
- 1935627
- 3010162973
- 1530530
- 1834331
- 3006356043
- 3036756245
- 8010099
- 3010057495
- 3002807561
- 1531050
- 1531174
- 3008110533
- 3010462278
- 1833824
- 1528646
- 2133928
- 3017780544
- 3005083075
- 3000270450
Source Documents#
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 |
| K253545 | Vulcan Spinal System | K2m, Inc. | 2026-02-10 |
| 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 |