510(k) Report

Devices descending from K070300

31 later devices reach Expedium SFX Cross Connector System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+1K081153Novel Spinal SystemMedyssey Co, Ltd.200923—
+1K083743Capsure PS SystemSpine Wave, Inc.20093—
+2K180433Ennovate®Aesculap Implant Systems, LLC201811
+2K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+2K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+2K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+2K111913Capsure (R) PS SystemSpine Wave, Inc.20111—
+2K110284Novel Iii Spinal Fixation and Adjustable Bridge SystemMedyssey Co, Ltd.201112—
+2K103147Novel Iii Spinal Fixation and Adjustable Bridge SystemMedyssey Co, Ltd.201013—
+2K093104Medyssey CO., LTD., Zenius Spinal SystemMedyssey Co, Ltd.201020—
+2K100122Modification to Capsure PS SystemSpine Wave, Inc.20102—
+3K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+3K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.20166—
+3K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+3K110283Zenius Spinal SystemMedyssey Co, Ltd.201114—
+3K103272Zenius Spinal SystemMedyssey Co, Ltd.201015—
+4K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+4K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+4K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+4K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+4K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+4K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+5K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—