510(k) Report

Devices descending from K043371

20 later devices reach Biomerix Vascular Occlusion Device and Loader through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+1K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation200817—
+2K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+2K211563Pitch-PatchsXiros, Ltd.20212—
+2K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+2K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+2K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+3K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—
+3K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+3K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+3K090288Orthadapt PRPegasus Biologics, Inc.20097—
+4K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG20260—
+4K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+4K112567Biomerix AssureBiomerix Corporation20110—
+4K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+5K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+6K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+6K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+6K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+7K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—