510(k) Report

Devices descending from K081153

23 later devices reach Novel Spinal System through their predicates, nearest generation first.

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