Product code NKB
- Device name
- Thoracolumbosacral Pedicle Screw System
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3070
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262091 | FRAXION Spinal Fixation System | Ortler Global Tibbi Gerecler Anonim Sirketi | 2026-09-17 |
| K262193 | RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology | Xenix Medical | 2026-09-14 |
| K262828 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026-09-04 |
| K253943 | Tiger 2 System | Zavation Medical Products, LLC | 2026-07-24 |
| K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) | MANTIZ Co., Ltd. | 2026-07-24 |
| 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 |
| K253545 | Vulcan Spinal System | K2m, Inc. | 2026-02-10 |
| K252461 | Swedge™ Pedicle Screw Fixation System Bezier Rod | Spinal Resources, Inc. | 2026-01-13 |
| K253941 | CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) | Medtronic Sofamor Danek USA, Inc. | 2026-01-07 |
| K253990 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026-01-07 |
| K253093 | Vital™ Spinal Fixation System | Highridge Medical, LLC | 2025-12-17 |
| K253721 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2025-12-17 |
| K252729 | Universal Spinal System | Double Medical Technology, Inc. | 2025-11-18 |
| K252730 | Fule Spinal Fixation System | Beijing Fule Science & Technology Development Co., Ltd. | 2025-10-24 |
| K253335 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2025-10-24 |
| K252346 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical | 2025-10-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00613994887955 | TSRH® Spinal System | MEDTRONIC SOFAMOR DANEK, INC. | 2015-09-17 |
| 00613994568823 | TSRH® Spinal System | MEDTRONIC SOFAMOR DANEK, INC. | 2015-08-05 |
| 00613994888143 | TSRH® Spinal System | MEDTRONIC SOFAMOR DANEK, INC. | 2015-08-05 |
| 00885074494722 | TSRH® Spinal System | MEDTRONIC SOFAMOR DANEK, INC. | 2015-08-05 |
| 00613994568311 | TSRH® Spinal System | MEDTRONIC SOFAMOR DANEK, INC. | 2015-08-05 |
| 04546540148735 | XIA II | Stryker Corporation | 2014-12-08 |
| 04546540148841 | XIA II | Stryker Corporation | 2014-12-08 |
| 04546540148742 | XIA II | Stryker Corporation | 2014-12-08 |
| 04546540148759 | XIA II | Stryker Corporation | 2014-12-08 |
| 04546540148766 | XIA II | Stryker Corporation | 2014-12-08 |
| 04546540148773 | XIA II | Stryker Corporation | 2014-12-08 |
| 04546540148780 | XIA II | Stryker Corporation | 2014-12-08 |
| 04546540148797 | XIA II | Stryker Corporation | 2014-12-08 |
| 04546540148803 | XIA II | Stryker Corporation | 2014-12-08 |
| 04546540148810 | XIA II | Stryker Corporation | 2014-12-08 |
| 04546540148827 | XIA II | Stryker Corporation | 2014-12-08 |
| 04546540148834 | XIA II | Stryker Corporation | 2014-12-08 |
| 04546540148025 | XIA II | Stryker Corporation | 2014-12-08 |
| 04546540148018 | XIA II | Stryker Corporation | 2014-12-08 |
| 04546540148001 | XIA II | Stryker Corporation | 2014-12-08 |
| 04546540147998 | XIA I | Stryker Corporation | 2014-12-08 |
| 04546540147981 | XIA I | Stryker Corporation | 2014-12-08 |
| 04546540147974 | XIA I | Stryker Corporation | 2014-12-08 |
| 04546540147936 | XIA I | Stryker Corporation | 2014-12-08 |
| 04546540147929 | XIA I | Stryker Corporation | 2014-12-08 |
| 04546540147912 | XIA I | Stryker Corporation | 2014-12-08 |
| 04546540147905 | XIA II | Stryker Corporation | 2014-12-08 |
| 04546540147806 | XIA II | Stryker Corporation | 2014-12-08 |
| 04546540147769 | XIA II | Stryker Corporation | 2014-12-08 |
| 04546540147257 | XIA II | Stryker Corporation | 2014-12-08 |