510(k) Report

Devices descending from K131878

8 later devices reach Lliad, Kora, Zenius Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+1K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+1K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+2K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+2K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+3K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—