510(k) Report

Devices descending from K911936

22 later devices reach Osteomed SBF System (SBF) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122049Neuropro Low Profile Cranial Plating SystemKinamed, Inc.20130—
+1K111176Osteomed Low Profile Neuro Fixation SystemOsteomed LP201112
+1K090522Osteomed Hand Plate and Screw Fixation SystemOsteomed LP200915—
+1K080694Osteomed Modular Locking Fixation SystemOsteomed LP20082—
+2K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+2K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE20190—
+2K143338Argulated Locking PlatesOsteomed LP20150—
+2K141123Alliance Spine Raas Cranial Plating SystemAlliance Partners, LLC20150—
+2K132769Acumed Hand Plating SystemAcumed, LLC20147—
+2K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+2K111419Osteomed Hand Fusion SystemOsteomed LP20111—
+3K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+3K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+3K141383Acumed Hand Fracture SystemAcumed, LLC20146—
+3K130120Extremity Medical IP Fusion SystemExtremity Medical, LLC20130—
+4K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+4K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+4K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+5K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+5K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+6K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+6K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—