510(k) K153442
- Device
- CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments For Use With The STEALTHSTATION System, Medtronic Reusable Instruments For Use With The IPC POWEREASE System, Medtronic Navigated Reusable Instruments For Use With The STEALTHS
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- 510(k) number
- K153442
- Product code
- NKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-02-18
- Date received
- 2015-11-27
- 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
- No
Applicant Contact#
- Contact
- Lila Joe
- 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 |
Legacy Summary#
summary
FDA Review#
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