510(k) Report

Devices descending from K984230

30 later devices reach Osteo-Mesh TM-300 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171774RPM Reinforced PTFE MeshOsteogenics Biomedical, Inc.20170—
+1K111761Neo Titanium Mesh, Cti-MemNeobiotech Co., Ltd.201217—
+1K102656Synthes Dentoalveolar Bone Fixation SystemSynthes (Usa)20101—
+1K091120Medpor Contain ImplantPorex Surgical, Inc.20101—
+1K050669Jeil Bone Fixation SystemJeil Medical Corporation20058—
+2K202918OsteoSync™ Ti Dental MeshSites Medical, LLC20210—
+2K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+2K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+2K182881Bone Screw, Bone TackOsstem Implant Co., Ltd.20191—
+2K170697GBR systemSurgident20182—
+2K143730GBR SystemJeil Medical Corporation20152—
+2K131289I-GENMegagen Implant Co., Ltd.20130—
+2K120951Smartbuilder SystemOsstem Implant Co., Ltd.201214—
+2K102184Medpor Contain Can ImplantPorex Surgical, Inc.20110—
+3K251569Bone ScrewOsstem Implant Co., Ltd.20250—
+3K222367Save GBRDentis Co., Ltd.20230—
+3K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+3K172354OssBuilder SystemOsstem Implant Co., Ltd.20183—
+3K160991Neo GBR SystemNeobiotech Co., Ltd.20171—
+3K140600SB AnchorOsstem Implant Co., Ltd.20144—
+3K130840Smartbuilder System (SB1)Osstem Implant Co., Ltd.20130—
+4K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+4K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+4K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+4K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K222451Save GBRDentis Co., Ltd.20230—
+4K192747Yxoss CBR®Reoss GmbH20200—
+4K181854OssBuilder SystemOsstem Implant Co., Ltd.20190—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—