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 |
|---|---|---|---|
| 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 |
| K253249 | TriALTIS™ Spine System | Medos International SARL | 2025-10-21 |
| K242827 | A8 INTEGR8™ Porous Pedicle Screws | Allumin8, Inc. | 2025-10-20 |
| K253331 | PressON Spinal Fixation System | Nexus Spine | 2025-10-14 |
| K252437 | JAZZ Spinal System | Implanet | 2025-08-28 |
| K251804 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2025-07-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840019935180 | Reform Ti | PRECISION SPINE, INC. | 2019-10-07 |
| 00840019935333 | Reform Ti | PRECISION SPINE, INC. | 2019-10-07 |
| 00840019935326 | Reform Ti | PRECISION SPINE, INC. | 2019-10-07 |
| 00840019935302 | Reform Ti | PRECISION SPINE, INC. | 2019-10-07 |
| 00840019935296 | Reform Ti | PRECISION SPINE, INC. | 2019-10-07 |
| 00840019935289 | Reform Ti | PRECISION SPINE, INC. | 2019-10-07 |
| 00840019935272 | Reform Ti | PRECISION SPINE, INC. | 2019-10-07 |
| 00840019935265 | Reform Ti | PRECISION SPINE, INC. | 2019-10-07 |
| 00840019935258 | Reform Ti | PRECISION SPINE, INC. | 2019-10-07 |
| 00840019935241 | Reform Ti | PRECISION SPINE, INC. | 2019-10-07 |
| 00840019935234 | Reform Ti | PRECISION SPINE, INC. | 2019-10-07 |
| 00840019935227 | Reform Ti | PRECISION SPINE, INC. | 2019-10-07 |
| 00840019935210 | Reform Ti | PRECISION SPINE, INC. | 2019-10-07 |
| 00840019935203 | Reform Ti | PRECISION SPINE, INC. | 2019-10-07 |
| 00840019935197 | Reform Ti | PRECISION SPINE, INC. | 2019-10-07 |
| 00840019935173 | Reform Ti | PRECISION SPINE, INC. | 2019-10-07 |
| 00840019935166 | Reform Ti | PRECISION SPINE, INC. | 2019-10-07 |
| 00840019935159 | Reform Ti | PRECISION SPINE, INC. | 2019-10-07 |
| 00840019935128 | Reform Ti | PRECISION SPINE, INC. | 2019-10-07 |
| 00840019934848 | Reform Ti | PRECISION SPINE, INC. | 2019-10-04 |
| 00840019935111 | Reform Ti | PRECISION SPINE, INC. | 2019-10-04 |
| 00840019935104 | Reform Ti | PRECISION SPINE, INC. | 2019-10-04 |
| 00840019935098 | Reform Ti | PRECISION SPINE, INC. | 2019-10-04 |
| 00840019935081 | Reform Ti | PRECISION SPINE, INC. | 2019-10-04 |
| 00840019935074 | Reform Ti | PRECISION SPINE, INC. | 2019-10-04 |
| 00840019934893 | Reform Ti | PRECISION SPINE, INC. | 2019-10-04 |
| 00840019934886 | Reform Ti | PRECISION SPINE, INC. | 2019-10-04 |
| 00840019934879 | Reform Ti | PRECISION SPINE, INC. | 2019-10-04 |
| 00840019934862 | Reform Ti | PRECISION SPINE, INC. | 2019-10-04 |
| 00840019934855 | Reform Ti | PRECISION SPINE, INC. | 2019-10-04 |