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HWC

Screw, Fixation, Bone

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)
1064 件

该代码近三年的 510(k)（53 件）

数据窗口为最近三年。最新一件：2026-08-24。

510(k) 号批准日期申请人器械名称
K2601062026-08-24Flower Orthopedics Corporation DBA ConOsteoCoil™ GT Active Compression System 摘要
K2623442026-08-12TriMed, Inc.Large Compression Screws 摘要
K2538582026-08-05T.A.G. Medical Products Corporation, LGFS - Sterile Screws and Top Hat 摘要
K2620752026-07-22Relja Innovations, LLCLapidus Screw Kit 摘要
K2608092026-06-25Arthrex, Inc.Arthrex Sterile VAL and VAL KreuLock™ Compression Sc 摘要
K2531082026-06-05Steps OrthoVEOFIX Snap Off Screw 摘要
K2611542026-05-30In2Bones USA, LLCCoLink® & CoLag® Non-Sterile Screws 摘要
K2612412026-05-14TriMed, Inc.TriMed Compression Screws 摘要
K2542152026-05-08Arthrex, Inc.Arthrex Beaming System 摘要
K2540772026-05-01OSSIO , Ltd.OSSIOfiber® Threaded Trimmable Fixation Nail 摘要
K2609342026-04-17Medartis AGTITAN Nail; APTUS K-Wire System 摘要
K2526992026-04-10University of Utah, Department of OrthCoAptix S System 摘要
K2530422026-04-03Tyber Medical, LLCTyber Medical Trauma Screw 摘要
K2541102026-03-18MedShape, Inc.DynaNail Mini; DynaNail Hybrid; DynaNail Helix; Dyna 摘要
K2603612026-03-06Treace Medical Concepts, Inc.Treace Medical Concepts (TMC) Screw Fixation System 摘要
K2529012025-12-31Tyber Medical, LLCTyber Medical Trauma Screw 摘要
K2515552025-11-06Pace SurgicalUltra™ Compression Screw System 摘要
K2523122025-10-10Dev4Eleganz IM Threaded Nail System (IM Threaded Nail Sy 摘要
K2505362025-10-08Extremity Medical, LLCMetaFore Small Screw System 摘要
K2527582025-10-02Orthonovis, Inc.Cannulated Screw and Kirschner (K wire) System 摘要
K2520192025-08-29Curvafix, Inc.CurvaFix Low Profile System 摘要
K2513822025-08-27Astra Orthomed, Inc.Phoenix Sinus Tarsi Stent System 摘要
K2508672025-08-15Dunamis Medical, LLCDunamis Screw and Suture Locking System 摘要
K2502512025-06-13Dev4Eleganz Fusion Screw System (Fusion Screw System) 摘要
K2439432025-04-10TriMed, Inc.TriMed® Compression Screws 摘要
K2506132025-04-02Nvision Biomedical Technologies, Inc.SnapHammer Hammertoe Correction System 摘要
K2503042025-03-05Vilex, LLCTITANEX Screw Systems 摘要
K2428962025-02-05Nvision Biomedical TechnologiesCaliber Intramedullary Fixation System 摘要
K2424422025-01-31Innovate Orthopaedics, Ltd.Quick-Start Orthopaedic Fixation Screw and Reverse T 摘要
K2431952025-01-10Arthrex, Inc.Arthrex SS VAL and VAL KreuLock™ Compression Screw S 摘要
K2423482024-12-04Double Medical Technology, Inc.Locking Screw,CoCrMo 摘要
K2335672024-11-22Flower Orthopedics Corporation Dba ConOsteoCoil™ Nitinol Compression System (Multiple Comp 摘要
K2401752024-10-29Tigon MedicalTigon Medical Fractures, Instability, and Reconstruc 摘要
K2426912024-10-09OsteoCentric TechnologiesOsteoCentric Technologies Cannulated Fasteners and N 摘要
K2426712024-10-04Treace Medical Concepts, Inc.Treace Medical Concepts (TMC) Screw Fixation System 摘要
K2415922024-08-31Arthrex, Inc.Arthrex VAL and VAL KreuLock™ Compression Screw Syst 摘要
K2413592024-08-02Medline Industries, LPMedline UNITE® MIS Foot Recon Screw System 摘要
K2412772024-07-03OSSIO , Ltd.OSSIOfiber® Threaded Trimmable Fixation Nail 摘要
K2408152024-06-13Arthrex, Inc.Arthrex Cannulated Screw System 摘要
K2330082024-06-05Aap Implantate AGCannulated Headless Bone Screws 摘要
K2405302024-03-21MedShape, Inc.DynaNail Mini Tapered Hybrid 摘要
K2339122024-03-11Jeil Medical CorporationARIX Cannulated Screw System 摘要
K2331982024-03-08OSSIO , Ltd.OSSIOfiber® Threaded Trimmable Fixation Nails 摘要
K2314532024-02-16Nvision Biomedical Technologies, Inc.SnapHammer Hammertoe Correction System 摘要
K2340402024-01-18TriMed, Inc.TriMed Threaded Intramedullary Nail System 摘要
K2318602024-01-18Tdm Co., Ltd.TDM Screw System 摘要
K2305072024-01-04Zimed MedikalZimed Distal Medial Tibial Plate and Screw System 摘要
K2333962023-12-21Smith & Nephew, Inc.Cannulated Screw System 摘要
K2322512023-11-03Medartis AGAPTUS Cannulated Compression Screws Line Extension, 摘要
K2312312023-10-12Paragon 28, Inc.MR Safety and Compatibility Testing and Labeling for 摘要
K2316492023-09-29Auxano Medical, LLCIntraosseous Fusion Device System 摘要
K2309462023-09-15Trax SurgicalAccelerate Compression Screw System-Small Product Co 摘要
K2315042023-09-11Vilex, LLCTITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Sc 摘要
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。