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KTT

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

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)
23 件
其中 Summary 已存档
22 份,可直接下载
FDA 历史累计 510(k)
404 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)(23 件)

数据窗口为最近三年。最新一件:2026-06-11。

510(k) 号批准日期申请人器械名称摘要
K2540872026-06-11Synthes (USA) Products, LLCMAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Corre…PDF
K2609002026-04-17Vilex, LLCDYNEX® External Fixation SystemsPDF
K2601122026-03-23Stabiliz Orthopaedics, Inc.QuikFix External Fixator: Knee-Spanning PackPDF
K2532912026-01-20Blue Ocean GlobalExcelsior SystemPDF
K2536132025-12-19Paragon 28, Inc.Monkey Rings External Ring Fixation SystemPDF
K2532022025-12-19Stryker GmbHHoffmann LRF SystemPDF
K2525552025-11-25Medusa Orthopedics, LLCMedusa Orthopedics Boa External Fixation SystemPDF
K2526252025-11-20Response Ortho Solutions, LLCThe Response Ortho Smart Fixator - Hexapod SystemFDA
K2521062025-09-30Paragon 28, Inc.External Fixation Mini Rail SystemPDF
K2518622025-08-11Paragon 28, Inc.External Fixation Bone DistractorPDF
K2504722025-08-08Amdt Holdings, Inc.SixFix™ Hexapod Fixator and Deformity Analysis and C…PDF
K2511282025-05-07Extremity Medical, LLCExtremity Medical External Fixation SystemPDF
K2437982025-03-07OrthoPediatrics Corp.Orthex External Fixation SystemPDF
K2415632025-02-21Extremity Medical, LLCExtremity Medical External Fixation SystemPDF
K2428612024-12-03Orthofix SrlTrueLok ElevatePDF
K2424522024-11-01Paragon 28, Inc.Monkey Bars Pin to Bar External Fixation SystemPDF
K2417692024-09-18Response Ortho Solutions, LLCResponse Ortho Metaphyseal Hinge Fixator SystemPDF
K2330252024-05-30New Standard Device Dba MetalogixRevolution External Plating SystemPDF
K2400492024-05-29Metric Medical Devices, Inc.LINK(TM) External FixatorPDF
K2337412023-12-21Stryker GmbHHoffmann LRF SystemPDF
K2217872023-11-30Auxein Medical Private LimitedAuxein's DHS/DCS Plate SystemPDF
K2328972023-10-18Arthrex, Inc.Arthrex Small External Fixation SystemPDF
K2328382023-10-12Paragon 28, Inc.Monkey RingsTM External Fixation SystemPDF

其中 22 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

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。