NKG
- 产品代码
- NKG
- 器械名称
- Posterior Cervical Screw System
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 888.3075
- 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)
- 118 件
FDA 分类定义
Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4) failed previous fusions; 5) tumors; 6) inflammatory disorders; 7) spinal degeneration, 8) facet degeneration with instability; and 9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to stabilize the spine in the absence of fusion for a limited time period in patients with tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
该代码近三年的 510(k)（16 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K253195 | 2026-06-02 | ZheJiang Decans Medical Devices Co., L | TAURUS Posterior Occipital-Cervico-Thoracic Spinal S 摘要 |
| K254045 | 2026-03-16 | CarboFix Orthopedics , Ltd. | CarboClear® Posterior Cervical Screw System; CarboCl 摘要 |
| K254165 | 2026-01-21 | Medtronic Sofamor Danek USA, Inc. | Infinity OCT System 摘要 |
| K252327 | 2025-11-12 | Icotec AG | CMORE® CT System; CMORE® CT System Navigated Instrum 摘要 |
| K253129 | 2025-10-24 | Medtronic Sofamor Danek USA, Inc. | Infinity OCT System 摘要 |
| K251725 | 2025-06-25 | Cg Medtech Co., Ltd. | ANAX OCT Spinal System 摘要 |
| K250866 | 2025-05-20 | Met One Technologies, LLC | Sovereign Posterior Cervical System 摘要 |
| K242674 | 2025-05-13 | Signature Orthopaedics Pty, Ltd. | Freedom Posterior Cervical Screws 摘要 |
| K250332 | 2025-04-04 | Highridge Medical, LLC | Virage® OCT Spinal Fixation System 摘要 |
| K242516 | 2024-11-19 | MiRus, LLC | EUROPA Posterior Cervical Fusion System 摘要 |
| K233989 | 2024-03-27 | CarboFix Orthopedics , Ltd. | CarboClear® Posterior Cervical Screw System 摘要 |
| K231850 | 2024-03-14 | Globus Medical, Inc. | QUARTEX® Occipito-Cervico-Thoracic Spinal System Exc 摘要 |
| K233332 | 2023-11-27 | K&J Consulting Corp. | Statera-C Spinal System 摘要 |
| K233078 | 2023-11-22 | Double Medical Technology, Inc. | Posterior Cervical Spine System 摘要 |
| K233366 | 2023-11-09 | Medos International SARL | SYMPHONY OCT System 摘要 |
| K232167 | 2023-09-27 | Vy Spine, LLC | VySpan PCT System 摘要 |
FDA 官方分类页： NKG
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。