510(k) Report

Devices descending from K963394

39 later devices reach Osteomed Tram through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983360Macropore Protective SheetPacific Materials and Interfaces19996—
+1K984230Osteo-Mesh TM-300Osteogenics Biomedical, Inc.199930—
+1K970841Imtec/Titanium MeshImtec Corp.19972—
+2K171774RPM Reinforced PTFE MeshOsteogenics Biomedical, Inc.20170—
+2K111761Neo Titanium Mesh, Cti-MemNeobiotech Co., Ltd.201217—
+2K102656Synthes Dentoalveolar Bone Fixation SystemSynthes (Usa)20101—
+2K091120Medpor Contain ImplantPorex Surgical, Inc.20101—
+2K050669Jeil Bone Fixation SystemJeil Medical Corporation20058—
+2K011569Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc.20025—
+3K202918OsteoSync™ Ti Dental MeshSites Medical, LLC20210—
+3K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+3K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+3K182881Bone Screw, Bone TackOsstem Implant Co., Ltd.20191—
+3K170697GBR systemSurgident20182—
+3K143730GBR SystemJeil Medical Corporation20152—
+3K131289I-GENMegagen Implant Co., Ltd.20130—
+3K120951Smartbuilder SystemOsstem Implant Co., Ltd.201214—
+3K102184Medpor Contain Can ImplantPorex Surgical, Inc.20110—
+3K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20073—
+3K042517Biosorb FX and Biosorb PDX 1.5 and 2.0 ScrewsLinvatec Biomaterials, Ltd.20040—
+4K251569Bone ScrewOsstem Implant Co., Ltd.20250—
+4K222367Save GBRDentis Co., Ltd.20230—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K172354OssBuilder SystemOsstem Implant Co., Ltd.20183—
+4K160991Neo GBR SystemNeobiotech Co., Ltd.20171—
+4K140600SB AnchorOsstem Implant Co., Ltd.20144—
+4K130840Smartbuilder System (SB1)Osstem Implant Co., Ltd.20130—
+4K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20082—
+5K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K222451Save GBRDentis Co., Ltd.20230—
+5K192747Yxoss CBR®Reoss GmbH20200—
+5K181854OssBuilder SystemOsstem Implant Co., Ltd.20190—
+5K121606Resorb-X GKLS-Martin L.P.20130—
+5K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+6K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—