510(k) Report

Devices descending from K111362

11 later devices reach Rexious Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222415Rexious Spinal Fixation SystemDio Medical Corporation20221—
+1K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+1K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+1K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+1K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd.20175—
+1K132365Spondylolisthesis Spinal Fixation, Spinal Pedicle FixationAccel Spine201322
+1K131522Core Pedicle Screw SystemCore-Nexus20130—
+2K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+2K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+2K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+2K140219Picasso II Mis Spinal SystemAccel Spine20141—