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HSB

Rod, Fixation, Intramedullary And Accessories

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)
530 件

该代码近三年的 510(k)（46 件）

数据窗口为最近三年。最新一件：2026-06-29。

510(k) 号批准日期申请人器械名称
K2614812026-06-29Stryker GmbHPangea Femur Reconstruction System 摘要
K2530802026-06-18Suzhou and Science & Technology DeveloAND Medical Femoral Nail System (PFNA01); AND Medica 摘要
K2616512026-06-18NuVasive Specialized OrthopedicsPrecice™ Max System and Precice™ Ankle Salvage Syste 摘要
K2531552026-06-17Beijing Fule Science & Technology DeveFule Metallic Lockable Intramedullary Nail Systems 摘要
K2530462026-06-16ZheJiang Decans Medical Devices Co., LHERA Interlocking Intramedullary Nailing System 摘要
K2601462026-05-19Orthofix SrlFITBONE® TRANSPORT AND LENGTHENING SYSTEM 摘要
K2539912026-05-08Orthofix SrlFitbone™ Trochanteric, FITBONE® Transport and Lengt 摘要
K2610432026-04-24Globus Medical, Inc.AUTOBAHN™ Nailing System 摘要
K2520162026-03-20Arthrex, Inc.Arthrex Humeral Nails 摘要
K2529612026-03-18Fusion Orthopedics USA, LLCFusion FibFix Nail 摘要
K2535662026-03-12Zimmer, Inc.Affixus Retrograde Femoral Nailing System 摘要
K2535172026-03-10Reselute, Inc.Reselute Tibial Nail 摘要
K2521962026-03-05Arthrex, Inc.Arthrex FibuLock Nail System 摘要
K2535912026-03-05Paragon 28, Inc.Phantom® Hindfoot TTC/TC Nail System 摘要
K2520252026-03-04Satori Orthopaedics, Inc.Active Intramedullary (AIM) Tibial Nail System 摘要
K2536402026-02-03Stryker GmbHT2 Alpha Femur Retrograde Nailing System; Pangea Fem 摘要
K2537492025-12-12Zimmer Switzerland Manufacturing GmbHAffixus® Natural Nail® Proximal Humeral System 摘要
K2528262025-12-10Jeil Medical CorporationARIX Femur Nail System 摘要
K2501972025-10-17Citieffe S.R.L.Estremo Fibular Nail 摘要
K2506282025-09-12MedShape, Inc.DynaNail TTC Fusion System 摘要
K2514002025-08-20Stryker GmbHT2 Alpha Humerus Nailing System; IMN Screws System; 摘要
K2501632025-08-13Stryker GmbHT2 Alpha Femur Retrograde Nailing System 摘要
K2506222025-08-07Ortho Solutions UK , Ltd.Succession™ AFN System 摘要
K2518502025-07-14Paragon 28, Inc.Phantom® Hindfoot TTC/TC Nail System 摘要
K2505592025-06-12Gm Dos Reis Industria E ComercioGMReis Fibula Nail System 摘要
K2422472025-04-22Jeil Medical CorporationARIX Femur Nail System 摘要
K2501122025-04-10Orthofix SrlFitboneTM Trochanteric 摘要
K2506232025-04-01OrthoPediatrics Corp.Pediatric Nailing Platform Tibia Pediatric Nailing 摘要
K2419832025-02-21Orthopediatrics Canada Ulc Dba Pega MeFassier-Duval Telescoping IM System 摘要
K2439072025-02-12Zimmer, Inc.Affixus Tibial Nailing System - 4mm screws 摘要
K2438902025-01-13Arthrex, Inc.Arthrex Intramedullary Nails 摘要
K2433642024-12-09Smith & Nephew, Inc.TRIGEN META-TAN Trochanteric Antegrade Nail 摘要
K2414842024-11-05Orthopedic Designs North America, Inc.Atlas™ Humeral Nail System 摘要
K2416512024-09-26Zimmer, Inc.Affixus Tibial and Antegrade Femoral Nailing System 摘要
K2300712024-08-22Tdm Co., Ltd.Femur Reconstruction Interlocking Nail System, Femur 摘要
K2341282024-08-22Paragon 28, Inc.Phantom Fibula Nail System 摘要
K2336962024-08-01DePuy SynthesDePuy Synthes Retrograde Femoral Nail Advanced Syste 摘要
K2338672024-06-18Orthofix SrlFitbone Trochanteric 摘要
K2326482024-05-03Orthofix SrlRODEO Telescopic Nail 摘要
K2339102024-04-04Orthoxel DacVertex Hip Fracture Nailing System 摘要
K2321692024-03-22Orthofix SrlFITBONE® Transport and Lengthening System 摘要
K2331342024-02-12I.T.S. GmbHI.T.S. INS Proximal Femur Nail 摘要
K2340752024-02-05Flow-Fx, LLCFlow-Nail 摘要
K2313432024-01-30Vilex, LLCRedemption Duo Hindfoot Nail System 摘要
K2322672023-12-15Nuvasive Specialized Orthopedics, IncoPrecice Max System 摘要
K2303522023-10-31Tornier, Inc.Tornier Humeral Nail and Tornier Long Humeral Nail 摘要
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。