KTT
- 产品代码
- KTT
- 器械名称
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 888.3030
- 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)
- 404 件
该代码近三年的 510(k)（23 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K254087 | 2026-06-11 | Synthes (USA) Products, LLC | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Corre 摘要 |
| K260900 | 2026-04-17 | Vilex, LLC | DYNEX® External Fixation Systems 摘要 |
| K260112 | 2026-03-23 | Stabiliz Orthopaedics, Inc. | QuikFix External Fixator: Knee-Spanning Pack 摘要 |
| K253291 | 2026-01-20 | Blue Ocean Global | Excelsior System 摘要 |
| K253613 | 2025-12-19 | Paragon 28, Inc. | Monkey Rings External Ring Fixation System 摘要 |
| K253202 | 2025-12-19 | Stryker GmbH | Hoffmann LRF System 摘要 |
| K252555 | 2025-11-25 | Medusa Orthopedics, LLC | Medusa Orthopedics Boa External Fixation System 摘要 |
| K252625 | 2025-11-20 | Response Ortho Solutions, LLC | The Response Ortho Smart Fixator - Hexapod System 摘要 |
| K252106 | 2025-09-30 | Paragon 28, Inc. | External Fixation Mini Rail System 摘要 |
| K251862 | 2025-08-11 | Paragon 28, Inc. | External Fixation Bone Distractor 摘要 |
| K250472 | 2025-08-08 | Amdt Holdings, Inc. | SixFix Hexapod Fixator and Deformity Analysis and C 摘要 |
| K251128 | 2025-05-07 | Extremity Medical, LLC | Extremity Medical External Fixation System 摘要 |
| K243798 | 2025-03-07 | OrthoPediatrics Corp. | Orthex External Fixation System 摘要 |
| K241563 | 2025-02-21 | Extremity Medical, LLC | Extremity Medical External Fixation System 摘要 |
| K242861 | 2024-12-03 | Orthofix Srl | TrueLok Elevate 摘要 |
| K242452 | 2024-11-01 | Paragon 28, Inc. | Monkey Bars Pin to Bar External Fixation System 摘要 |
| K241769 | 2024-09-18 | Response Ortho Solutions, LLC | Response Ortho Metaphyseal Hinge Fixator System 摘要 |
| K233025 | 2024-05-30 | New Standard Device Dba Metalogix | Revolution External Plating System 摘要 |
| K240049 | 2024-05-29 | Metric Medical Devices, Inc. | LINK(TM) External Fixator 摘要 |
| K233741 | 2023-12-21 | Stryker GmbH | Hoffmann LRF System 摘要 |
| K221787 | 2023-11-30 | Auxein Medical Private Limited | Auxein's DHS/DCS Plate System 摘要 |
| K232897 | 2023-10-18 | Arthrex, Inc. | Arthrex Small External Fixation System 摘要 |
| K232838 | 2023-10-12 | Paragon 28, Inc. | Monkey RingsTM External Fixation System 摘要 |
FDA 官方分类页： KTT
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。