NKB
- 产品代码
- NKB
- 器械名称
- Thoracolumbosacral Pedicle Screw System
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 888.3070
- FDA 专业组
- Orthopedic
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 属植入器械
- 该代码近三年的 510(k)
- 905 件
FDA 分类定义
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
该代码近三年的 510(k)（104 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K253943 | 2026-07-24 | Zavation Medical Products, LLC | Tiger 2 System 摘要 |
| K260362 | 2026-07-24 | MANTIZ Co., Ltd. | QUATTRO Spinal system (Open Configuration); QUATTRO- 摘要 |
| K261284 | 2026-07-14 | Alphatec Spine, Inc. | Invictus® Small Stature Spinal Fixation System; Invi 摘要 |
| K253802 | 2026-07-01 | S.M.A.I.O | KHEIRON® Spinal Fixation System, including patient s 摘要 |
| K253045 | 2026-06-17 | Socko Medical Co., Ltd. | Socko Vimax Spinal Fixation System 摘要 |
| K251251 | 2026-06-09 | Chanpin Medtak Co., Ltd. | ChanPin Pedicle Screw Spinal System 摘要 |
| K260989 | 2026-05-15 | Kyocera Medical Technologies Inc. (KMT | Varion Thoracolumbar Fixation System 摘要 |
| K253739 | 2026-05-07 | Globus Medical, Inc. | SCRIPT Rods, CREO Stabilization System, REVERE® S 摘要 |
| K261130 | 2026-05-05 | L&K BIOMED Co., Ltd. | AccelFix Spinal Fixation System 摘要 |
| K253966 | 2026-05-01 | Spineart SA | PERLA® TL Posterior Thoraco-lumbar Fixation System 摘要 |
| K252542 | 2026-04-29 | ZheJiang Decans Medical Devices Co., L | LEO Spinal System 摘要 |
| K253940 | 2026-04-28 | Medacta International S.A. | M.U.S.T. Pedicle Screw System - Extension 摘要 |
| K260216 | 2026-04-21 | Medtronic Sofamor Danek USA, Inc. | CD Horizon ModuLeX Fenestrated Screw Set; CD Horiz 摘要 |
| K254274 | 2026-04-16 | Life Spine, Inc. | ARx® SAI Implant System 摘要 |
| K260786 | 2026-04-03 | S.M.A.I.O | KHEIRON® Spinal Fixation System, including patient s 摘要 |
| K254247 | 2026-02-24 | Osteomni, Inc. | OSTEOMNI SPINAL FIXATION SYSTEM 摘要 |
| K253169 | 2026-02-23 | Box Spine, LLC | Duet Spinal Fixation System 摘要 |
| K253545 | 2026-02-10 | K2m, Inc. | Vulcan Spinal System 摘要 |
| K252461 | 2026-01-13 | Spinal Resources, Inc. | Swedge Pedicle Screw Fixation System Bezier Rod 摘要 |
| K253941 | 2026-01-07 | Medtronic Sofamor Danek USA, Inc. | CD Horizon ModuLeX Spinal System (LigaMAS Head Ass 摘要 |
| K253990 | 2026-01-07 | S.M.A.I.O | KHEIRON® Spinal Fixation System, including patient s 摘要 |
| K253721 | 2025-12-17 | S.M.A.I.O | KHEIRON® Spinal Fixation System, including patient s 摘要 |
| K253093 | 2025-12-17 | Highridge Medical, LLC | Vital Spinal Fixation System 摘要 |
| K252729 | 2025-11-18 | Double Medical Technology, Inc. | Universal Spinal System 摘要 |
| K252730 | 2025-10-24 | Beijing Fule Science & Technology Deve | Fule Spinal Fixation System 摘要 |
| K253335 | 2025-10-24 | Medtronic Sofamor Danek USA, Inc. | CD Horizon Spinal System 摘要 |
| K252346 | 2025-10-21 | Astura Medical | OLYMPIC Posterior Spinal Fixation System; MASADA Mod 摘要 |
| K253249 | 2025-10-21 | Medos International SARL | TriALTIS Spine System 摘要 |
| K242827 | 2025-10-20 | Allumin8, Inc. | A8 INTEGR8 Porous Pedicle Screws 摘要 |
| K253331 | 2025-10-14 | Nexus Spine | PressON Spinal Fixation System 摘要 |
| K252437 | 2025-08-28 | Implanet | JAZZ Spinal System 摘要 |
| K251804 | 2025-07-08 | S.M.A.I.O | KHEIRON® Spinal Fixation System, including patient s 摘要 |
| K251719 | 2025-07-01 | Ulrich Medical USA, Inc. | Momentum® Posterior Spinal Fixation System 摘要 |
| K250908 | 2025-06-18 | SeaSpine Orthopedics Corporation | Virata Spinal Fixation System 摘要 |
| K251154 | 2025-06-12 | Ht Medical D.B.A. Xenix Medical | RIVA Posterior Fixation System; RIVA Posterior Fixat 摘要 |
| K251131 | 2025-06-06 | Spine Wave, Inc. | Annex® 2 Adjacent Level System 摘要 |
| K250582 | 2025-05-08 | CG Bio Co., Ltd. | COLONNADE Posterior Screw Fixation System 摘要 |
| K241663 | 2025-04-28 | Eminent Spine | Eminent Spine 3D Titanium Pedicle Screw System 摘要 |
| K250092 | 2025-03-27 | HC Biologics, LLC | HC Biologics Osteopoint Spinal Fixation System 摘要 |
| K242900 | 2025-02-27 | Icotec AG | VADER® Pedicle System and VADER®one Pedicle System 摘要 |
| K243916 | 2025-02-21 | Spinal Elements, Inc. | Primus Spinal Fixation System 摘要 |
| K243908 | 2025-02-03 | Zavation Medical Products, LLC | Tiger 2 System 摘要 |
| K243249 | 2025-01-17 | Medos International SARL | TriALTIS Spine System 摘要 |
| K243946 | 2025-01-15 | Effortmed, LLC | EffortMed Spinal Fixation System 摘要 |
| K243259 | 2025-01-07 | Astura Medical | MASADA Modular Spinal Fixation System 摘要 |
| K243693 | 2024-12-23 | Neo Medical SA | NEO Pedicle Screw System 摘要 |
| K242297 | 2024-12-17 | Precision Spine, Inc. | Reform Pedicle Screw System 摘要 |
| K243281 | 2024-12-13 | Lock-In USA Corp | LOCK-IN Spinal Fixation System 摘要 |
| K231655 | 2024-11-26 | Solco Biomedical Co., Ltd. | 4CIS® Chiron Spinal Fixation System 摘要 |
| K242764 | 2024-11-13 | Cmf Medicon Surgical, Inc. | MediRod Pedicle Screw System 摘要 |
| K243004 | 2024-11-08 | Jeil Medical Corporation | Xpine Spinal Fixation System 摘要 |
| K243106 | 2024-11-05 | CarboFix Orthopedics , Ltd. | CarboClear® Hybrid Pedicle Screw System 摘要 |
| K242350 | 2024-10-28 | Spinal Alignment Solutions, Inc. | Spinal Alignment Solutions Pelvic Incidence (PI) Rod 摘要 |
| K243007 | 2024-10-23 | Medtronic Sofamor Danek USA, Inc. | CD Horizon Spinal System 摘要 |
| K242899 | 2024-10-17 | Baui Biotech Co., Ltd. | NOVA Minimally Invasive System 摘要 |
| K230325 | 2024-10-10 | Greens Surgicals Pvt. , Ltd. | GREENS BRAND Posterior, Non-cervical Pedicle Screw S 摘要 |
| K241657 | 2024-09-30 | Mikron Makina Sanayi VE Ticaret Ltd. S | MSFX MIKRON SPINAL FIXATION SYSTEM 摘要 |
| K240233 | 2024-09-09 | S.H.Pitkar Orthotools Pvt. , Ltd. | Pitkar Spinal Pedicle Screw System 摘要 |
| K242042 | 2024-09-09 | Medos International SARL | TriALTIS Spine System 摘要 |
| K242069 | 2024-09-03 | Eminent Spine | Eminent Spine Scoliosis Deformity Pedicle Screw Syst 摘要 |
| K240180 | 2024-08-30 | Orthopeasia Co., Ltd. | Orthopeasia Spinal Fixation System 摘要 |
| K241892 | 2024-08-02 | Xtant Medical Holdings, Inc. | Cortera Spinal Fixation System 摘要 |
| K233793 | 2024-08-01 | CarboFix Orthopedics , Ltd. | CarboClear® X Pedicle Screw System 摘要 |
| K241494 | 2024-07-26 | Pantheon Spinal | Pantheon Pedicle Screw and Iliac Bolt Fixation Syste 摘要 |
| K241863 | 2024-07-24 | Clariance | Erisma® Lp Spinal Fixation System; Erisma® LP MIS 摘要 |
| K241519 | 2024-06-21 | Alphatec Spine, Inc. | Invictus® Small Stature Spinal Fixation System 摘要 |
| K240963 | 2024-06-06 | Teslake, Inc. | Spinal System 摘要 |
| K241258 | 2024-06-04 | Ingenium Spine | Ingenix Spinal System 摘要 |
| K241276 | 2024-05-20 | Innovasis, Inc. | Vector Pedicle Screw System 摘要 |
| K240685 | 2024-05-06 | Spine Wave, Inc. | Salvo® Spine System 摘要 |
| K240392 | 2024-05-06 | Implanet | JAZZ Spinal System 摘要 |
| K240526 | 2024-04-29 | Stryker Instruments | POWEReam Xia/Serrato 摘要 |
| K240872 | 2024-04-26 | Clariance | Erisma® Deformity Spinal System; Erisma® Lp Spinal F 摘要 |
| K240846 | 2024-04-25 | CarboFix Orthopedics , Ltd. | CarboClear® Hybrid Pedicle Screw System; CarboClear® 摘要 |
| K232566 | 2024-04-19 | SeaSpine Orthopedics Corporation | NewPort Spinal System; Daytona Small Stature Spinal 摘要 |
| K240737 | 2024-04-05 | G Surgical, LLC | G Surgical Marksman MIS System 摘要 |
| K240350 | 2024-04-03 | GS Medical Co., Ltd. | AnyPlus II Spinal Fixation System 摘要 |
| K233951 | 2024-03-27 | Medtronic Sofamor Danek USA, Inc. | CD Horizon ModuLeX Spinal System (Shanks, Head Assem 摘要 |
| K240539 | 2024-03-15 | Zimvie Spine (Zimmer Biomet Spine, Inc | Vital Spinal Fixation System 摘要 |
| K232607 | 2024-02-27 | Solco Biomedical Copany India Private | 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CI 摘要 |
| K232628 | 2024-02-26 | Icotec AG | VADER® Pedicle System 摘要 |
| K234048 | 2024-02-13 | Medacta International S.A. | M.U.S.T. Pedicle Screw System - Extension 摘要 |
| K233960 | 2024-02-06 | Innosys Co., Ltd. | INNOVERSE Spinal System 摘要 |
| K233944 | 2024-01-10 | CarboFix Orthopedics , Ltd. | CarboClear® X Pedicle Screw System; CarboClear® X Na 摘要 |
| K233300 | 2023-12-26 | Stryker Instruments | POWEReam 1/4 Drive 摘要 |
| K233455 | 2023-12-12 | Life Spine, Inc. | ARx MIS Spinal Screw System 摘要 |
| K233684 | 2023-12-12 | Medos International SARL | TriALTIS Spine System 摘要 |
| K231443 | 2023-11-21 | Osteomed Indústria E Comércio DE Impla | Mini-OSTEO Pedicle Fixation System 摘要 |
| K232719 | 2023-11-21 | Premia Spine, Ltd. | ProMIS Extension Rod System 摘要 |
| K231694 | 2023-11-16 | Astura Medical | MASADA Modular Spinal Fixation System 摘要 |
| K233234 | 2023-10-26 | Nexus Spine, LLC | PressON Spinal Fixation System 摘要 |
| K231737 | 2023-10-26 | Innosys Co., Ltd. | ANAX 5.5 Spinal System 摘要 |
| K231069 | 2023-10-25 | Spineart SA | PERLA® TL Posterior Thoraco-lumbar Fixation System 摘要 |
| K232586 | 2023-10-24 | K&J Consulting Corp. | Rexious Spinal Fixation System, Statera Spinal Syst 摘要 |
| K232561 | 2023-10-23 | Sagico VA USA, LLC | Ripley Spinal Screw System by SAGICO 摘要 |
| K231744 | 2023-10-13 | Vy Spine, LLC | VyLink Spinal Screw System 摘要 |
| K230116 | 2023-10-11 | Zimvie Spine (Zimmer Biomet Spine, Inc | Vital Spinal Fixation System 摘要 |
| K230961 | 2023-10-10 | Shanghai Sanyou Medical Co, Ltd. | Zeus Spinal System 摘要 |
| K231658 | 2023-10-10 | Spineway | VEOS Spinal Fixation System 摘要 |
| K232341 | 2023-10-10 | CarboFix Orthopedics , Ltd. | CarboClear® Pedicle Screw System 摘要 |
| K232650 | 2023-09-29 | S.M.A.I.O | KHEIRON® Spinal Fixation System, including patient s 摘要 |
| K232275 | 2023-09-27 | Alphatec Spine, Inc. | Invictus® Spinal Fixation System 摘要 |
| K231479 | 2023-09-22 | Medos International SARL | TriALTIS Spine System 摘要 |
| K230974 | 2023-09-15 | Kalitec Medical | NIDO Pedicle Screw System 摘要 |
FDA 官方分类页： NKB
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。