HWC
- 产品代码
- HWC
- 器械名称
- Screw, Fixation, Bone
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 888.3040
- 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)
- 53 件
- 其中 Summary 已存档
- 49 份，可直接下载
- FDA 历史累计 510(k)
- 1064 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)（53 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260106 | 2026-08-24 | Flower Orthopedics Corporation DBA Con… | OsteoCoil GT Active Compression System | |
| K262344 | 2026-08-12 | TriMed, Inc. | Large Compression Screws | |
| K253858 | 2026-08-05 | T.A.G. Medical Products Corporation, L… | GFS - Sterile Screws and Top Hat | |
| K262075 | 2026-07-22 | Relja Innovations, LLC | Lapidus Screw Kit | |
| K260809 | 2026-06-25 | Arthrex, Inc. | Arthrex Sterile VAL and VAL KreuLock Compression Sc… | |
| K253108 | 2026-06-05 | Steps Ortho | VEOFIX Snap Off Screw | |
| K261154 | 2026-05-30 | In2Bones USA, LLC | CoLink® & CoLag® Non-Sterile Screws | |
| K261241 | 2026-05-14 | TriMed, Inc. | TriMed Compression Screws | |
| K254215 | 2026-05-08 | Arthrex, Inc. | Arthrex Beaming System | |
| K254077 | 2026-05-01 | OSSIO , Ltd. | OSSIOfiber® Threaded Trimmable Fixation Nail | FDA |
| K260934 | 2026-04-17 | Medartis AG | TITAN Nail; APTUS K-Wire System | |
| K252699 | 2026-04-10 | University of Utah, Department of Orth… | CoAptix S System | |
| K253042 | 2026-04-03 | Tyber Medical, LLC | Tyber Medical Trauma Screw | |
| K254110 | 2026-03-18 | MedShape, Inc. | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; Dyna… | |
| K260361 | 2026-03-06 | Treace Medical Concepts, Inc. | Treace Medical Concepts (TMC) Screw Fixation System | |
| K252901 | 2025-12-31 | Tyber Medical, LLC | Tyber Medical Trauma Screw | |
| K251555 | 2025-11-06 | Pace Surgical | Ultra Compression Screw System | |
| K252312 | 2025-10-10 | Dev4 | Eleganz IM Threaded Nail System (IM Threaded Nail Sy… | |
| K250536 | 2025-10-08 | Extremity Medical, LLC | MetaFore Small Screw System | |
| K252758 | 2025-10-02 | Orthonovis, Inc. | Cannulated Screw and Kirschner (K wire) System | |
| K252019 | 2025-08-29 | Curvafix, Inc. | CurvaFix Low Profile System | |
| K251382 | 2025-08-27 | Astra Orthomed, Inc. | Phoenix Sinus Tarsi Stent System | |
| K250867 | 2025-08-15 | Dunamis Medical, LLC | Dunamis Screw and Suture Locking System | |
| K250251 | 2025-06-13 | Dev4 | Eleganz Fusion Screw System (Fusion Screw System) | |
| K243943 | 2025-04-10 | TriMed, Inc. | TriMed® Compression Screws | |
| K250613 | 2025-04-02 | Nvision Biomedical Technologies, Inc. | SnapHammer Hammertoe Correction System | |
| K250304 | 2025-03-05 | Vilex, LLC | TITANEX Screw Systems | FDA |
| K242896 | 2025-02-05 | Nvision Biomedical Technologies | Caliber Intramedullary Fixation System | |
| K242442 | 2025-01-31 | Innovate Orthopaedics, Ltd. | Quick-Start Orthopaedic Fixation Screw and Reverse T… | |
| K243195 | 2025-01-10 | Arthrex, Inc. | Arthrex SS VAL and VAL KreuLock Compression Screw S… | |
| K242348 | 2024-12-04 | Double Medical Technology, Inc. | Locking Screw,CoCrMo | |
| K233567 | 2024-11-22 | Flower Orthopedics Corporation Dba Con… | OsteoCoil Nitinol Compression System (Multiple Comp… | |
| K240175 | 2024-10-29 | Tigon Medical | Tigon Medical Fractures, Instability, and Reconstruc… | |
| K242691 | 2024-10-09 | OsteoCentric Technologies | OsteoCentric Technologies Cannulated Fasteners and N… | |
| K242671 | 2024-10-04 | Treace Medical Concepts, Inc. | Treace Medical Concepts (TMC) Screw Fixation System | |
| K241592 | 2024-08-31 | Arthrex, Inc. | Arthrex VAL and VAL KreuLock Compression Screw Syst… | |
| K241359 | 2024-08-02 | Medline Industries, LP | Medline UNITE® MIS Foot Recon Screw System | FDA |
| K241277 | 2024-07-03 | OSSIO , Ltd. | OSSIOfiber® Threaded Trimmable Fixation Nail | |
| K240815 | 2024-06-13 | Arthrex, Inc. | Arthrex Cannulated Screw System | |
| K233008 | 2024-06-05 | Aap Implantate AG | Cannulated Headless Bone Screws | |
| K240530 | 2024-03-21 | MedShape, Inc. | DynaNail Mini Tapered Hybrid | |
| K233912 | 2024-03-11 | Jeil Medical Corporation | ARIX Cannulated Screw System | |
| K233198 | 2024-03-08 | OSSIO , Ltd. | OSSIOfiber® Threaded Trimmable Fixation Nails | |
| K231453 | 2024-02-16 | Nvision Biomedical Technologies, Inc. | SnapHammer Hammertoe Correction System | |
| K234040 | 2024-01-18 | TriMed, Inc. | TriMed Threaded Intramedullary Nail System | |
| K231860 | 2024-01-18 | Tdm Co., Ltd. | TDM Screw System | |
| K230507 | 2024-01-04 | Zimed Medikal | Zimed Distal Medial Tibial Plate and Screw System | |
| K233396 | 2023-12-21 | Smith & Nephew, Inc. | Cannulated Screw System | |
| K232251 | 2023-11-03 | Medartis AG | APTUS Cannulated Compression Screws Line Extension, … | |
| K231231 | 2023-10-12 | Paragon 28, Inc. | MR Safety and Compatibility Testing and Labeling for… | |
| K231649 | 2023-09-29 | Auxano Medical, LLC | Intraosseous Fusion Device System | |
| K230946 | 2023-09-15 | Trax Surgical | Accelerate Compression Screw System-Small Product Co… | |
| K231504 | 2023-09-11 | Vilex, LLC | TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Sc… | FDA |
FDA 官方分类页： HWC
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。