510(k) Report

Devices descending from K983495

84 later devices reach Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191009Arsenal Plating SystemTrilliant Surgical20192—
+1K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+1K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+1K150376Sonoma Cancellous Bone Screw and WasherSonoma Orthopedics Products, Inc.20150—
+1K111432Evolve (R) Triad (TM) Plating System and Evolve (R) Triad (TM) Bone ScrewsWrightmedicaltechnologyinc20112—
+1K092889Syntec Osteo-Plate and Screw FixationSyntec Scientific Corp.201013—
+1K090839Modification to Syntec-Taichun Non-Sterile Bone Plate and Screw ImplantsSyntec Scientific Corp.20090—
+1K072562Microware Bone Plates and Bone ScrewsMicroware Precision Co., Ltd.200825—
+1K080778Ensplint TM Bone ScrewSonoma Orthopedic Products, Inc.20080—
+1K072411Aap Bone Plates and Screw ImplantsAap Implantate AG20089—
+1K063020Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate SystemIntai Technology, Inc.200629—
+2K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+2K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+2K223772PRO Plating System, Stryker Trauma Pelvic Set (Matta)Stryker GmbH20231—
+2K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+2K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+2K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+2K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+2K200062Foot and Ankle SystemLeith Medical, LLC20210—
+2K201149CoLink Plating SystemIn2bones USA, LLC20200—
+2K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+2K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+2K190830TDM Screw SystemsTdm Co., Ltd.20191—
+2K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+2K182818LOQTEQ VA Calcaneus Plate 3.5Aap Implantate AG20190—
+2K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+2K181587ORTHOLOC SPS Shoulder Plating SystemTornier, Inc.20181—
+2K171904Tandry Locking Plate SystemMicroware Precision Co., Ltd.201811—
+2K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+2K161703LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, WasherAap Implantate AG20160—
+2K150974aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, TitaniumAap Implantate AG20150—
+2K150188SMV Scientific 4.5 mm Bone ScrewsSummit Medventures20150—
+2K141949Cortical Screw 3.5, T15, Self-Tapping, Titanium, Cortical Screw 4.5, T25, Self Tapping…Aap Implantate AG20140—
+2K130108Double Engine Bone Plate and Screw SystemsXiamen Double Engine Medical Material Co., Ltd.20139—
+2K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+2K111008Microware Bone Plates and Bone ScrewMicroware Precision Co., Ltd.20120—
+2K112819Reconstruction Locking Plate and 3.5MM Locking ScrewXiamen Double Engline Medical Material Co., Ltd.20111—
+2K092493GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate SystemGpc Medical, Ltd.201014—
+2K090786Kens Internal Fixation SystemKens Finemedtech Sdn. Bhd20091—
+3K254280F.A.S.T ScrewSteps Ortho20260—
+3K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+3K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+3K240958Locking Plates and Screws SystemsHebei Ruihe Medical Devices Co., Ltd.20250—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+3K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+3K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+3K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+3K231860TDM Screw SystemTdm Co., Ltd.20240—
+3K230690Tandry Locking Plate SystemMicroware Precision Co., Ltd.20231—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+3K221088Anatomic Bone PlateDouble Medical Technology, Inc.20231—
+3K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+3K220921Metal Bone ScrewDouble Medical Technology, Inc.20221—
+3K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+3K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+3K202971DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20212—
+3K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+3K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+3K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+3K191711ORTHOLOC™ SPS Shoulder Plating SystemTornier, Inc.20190—
+3K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+3K153573ConvergeBiomedical Enterprises, Inc.20160—
+3K151508IRENE Locking Compression Plate SystemTianjin Zhengtian Medical Instrument Co., Ltd.20160—
+3K142943Metallic Locking Bone Plate and ScrewCanwell Medical Co., Ltd.20150—
+3K141825IDEAL Locking Plate SystemJiangsu Ideal Medical Science & Technology Co., LT20150—
+3K143023Nitinol Compression Plating SystemBiomedical Enterprises, Inc.20152—
+3K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc.20115—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+4K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+4K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+4K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+4K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+4K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20220—
+4K161303dynaMX™ Compression PlateMx Orthopedics, Corp.20171—
+4K143721PRCT2Fx Solutions20150—
+4K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+4K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga20142—
+5K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+5K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+5K193345Arthrex DynaNite Compression PlateArthrex, Inc.20200—