HSB
- 产品代码
- HSB
- 器械名称
- Rod, Fixation, Intramedullary And Accessories
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 888.3020
- 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)
- 46 件
- 其中 Summary 已存档
- 42 份，可直接下载
- FDA 历史累计 510(k)
- 530 件（全部年份；本站只收录近三年的明细）
该代码近三年的 510(k)（46 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K261481 | 2026-06-29 | Stryker GmbH | Pangea Femur Reconstruction System | |
| K253080 | 2026-06-18 | Suzhou and Science & Technology Develo… | AND Medical Femoral Nail System (PFNA01); AND Medica… | |
| K261651 | 2026-06-18 | NuVasive Specialized Orthopedics | Precice Max System and Precice Ankle Salvage Syste… | |
| K253155 | 2026-06-17 | Beijing Fule Science & Technology Deve… | Fule Metallic Lockable Intramedullary Nail Systems | |
| K253046 | 2026-06-16 | ZheJiang Decans Medical Devices Co., L… | HERA Interlocking Intramedullary Nailing System | |
| K260146 | 2026-05-19 | Orthofix Srl | FITBONE® TRANSPORT AND LENGTHENING SYSTEM | |
| K253991 | 2026-05-08 | Orthofix Srl | Fitbone Trochanteric, FITBONE® Transport and Lengt… | |
| K261043 | 2026-04-24 | Globus Medical, Inc. | AUTOBAHN Nailing System | |
| K252016 | 2026-03-20 | Arthrex, Inc. | Arthrex Humeral Nails | |
| K252961 | 2026-03-18 | Fusion Orthopedics USA, LLC | Fusion FibFix Nail | |
| K253566 | 2026-03-12 | Zimmer, Inc. | Affixus Retrograde Femoral Nailing System | |
| K253517 | 2026-03-10 | Reselute, Inc. | Reselute Tibial Nail | |
| K252196 | 2026-03-05 | Arthrex, Inc. | Arthrex FibuLock Nail System | |
| K253591 | 2026-03-05 | Paragon 28, Inc. | Phantom® Hindfoot TTC/TC Nail System | |
| K252025 | 2026-03-04 | Satori Orthopaedics, Inc. | Active Intramedullary (AIM) Tibial Nail System | |
| K253640 | 2026-02-03 | Stryker GmbH | T2 Alpha Femur Retrograde Nailing System; Pangea Fem… | |
| K253749 | 2025-12-12 | Zimmer Switzerland Manufacturing GmbH | Affixus® Natural Nail® Proximal Humeral System | |
| K252826 | 2025-12-10 | Jeil Medical Corporation | ARIX Femur Nail System | FDA |
| K250197 | 2025-10-17 | Citieffe S.R.L. | Estremo Fibular Nail | |
| K250628 | 2025-09-12 | MedShape, Inc. | DynaNail TTC Fusion System | |
| K251400 | 2025-08-20 | Stryker GmbH | T2 Alpha Humerus Nailing System; IMN Screws System; … | |
| K250163 | 2025-08-13 | Stryker GmbH | T2 Alpha Femur Retrograde Nailing System | |
| K250622 | 2025-08-07 | Ortho Solutions UK , Ltd. | Succession AFN System | FDA |
| K251850 | 2025-07-14 | Paragon 28, Inc. | Phantom® Hindfoot TTC/TC Nail System | |
| K250559 | 2025-06-12 | Gm Dos Reis Industria E Comercio | GMReis Fibula Nail System | |
| K242247 | 2025-04-22 | Jeil Medical Corporation | ARIX Femur Nail System | |
| K250112 | 2025-04-10 | Orthofix Srl | FitboneTM Trochanteric | |
| K250623 | 2025-04-01 | OrthoPediatrics Corp. | Pediatric Nailing Platform Tibia Pediatric Nailing … | FDA |
| K241983 | 2025-02-21 | Orthopediatrics Canada Ulc Dba Pega Me… | Fassier-Duval Telescoping IM System | |
| K243907 | 2025-02-12 | Zimmer, Inc. | Affixus Tibial Nailing System - 4mm screws | |
| K243890 | 2025-01-13 | Arthrex, Inc. | Arthrex Intramedullary Nails | |
| K243364 | 2024-12-09 | Smith & Nephew, Inc. | TRIGEN META-TAN Trochanteric Antegrade Nail | |
| K241484 | 2024-11-05 | Orthopedic Designs North America, Inc.… | Atlas Humeral Nail System | |
| K241651 | 2024-09-26 | Zimmer, Inc. | Affixus Tibial and Antegrade Femoral Nailing System | |
| K230071 | 2024-08-22 | Tdm Co., Ltd. | Femur Reconstruction Interlocking Nail System, Femur… | |
| K234128 | 2024-08-22 | Paragon 28, Inc. | Phantom Fibula Nail System | |
| K233696 | 2024-08-01 | DePuy Synthes | DePuy Synthes Retrograde Femoral Nail Advanced Syste… | FDA |
| K233867 | 2024-06-18 | Orthofix Srl | Fitbone Trochanteric | |
| K232648 | 2024-05-03 | Orthofix Srl | RODEO Telescopic Nail | |
| K233910 | 2024-04-04 | Orthoxel Dac | Vertex Hip Fracture Nailing System | |
| K232169 | 2024-03-22 | Orthofix Srl | FITBONE® Transport and Lengthening System | |
| K233134 | 2024-02-12 | I.T.S. GmbH | I.T.S. INS Proximal Femur Nail | |
| K234075 | 2024-02-05 | Flow-Fx, LLC | Flow-Nail | |
| K231343 | 2024-01-30 | Vilex, LLC | Redemption Duo Hindfoot Nail System | |
| K232267 | 2023-12-15 | Nuvasive Specialized Orthopedics, Inco… | Precice Max System | |
| K230352 | 2023-10-31 | Tornier, Inc. | Tornier Humeral Nail and Tornier Long Humeral Nail |
FDA 官方分类页： HSB
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。