510(k) Report

Devices descending from K100765

23 later devices reach Fixpine II System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231737ANAX™ 5.5 Spinal SystemInnosys Co., Ltd.20231—
+1K222415Rexious Spinal Fixation SystemDio Medical Corporation20221—
+1K143417ANAX 5.5 Spinal SystemU&I Corporation20154—
+1K132101Anax 5.5 Spinal SystemU&I Corporation201313—
+1K132365Spondylolisthesis Spinal Fixation, Spinal Pedicle FixationAccel Spine201322
+1K131522Core Pedicle Screw SystemCore-Nexus20130—
+1K111362Rexious Spinal Fixation SystemDio Medical Co., Ltd.201111—
+2K233960INNOVERSE Spinal SystemInnosys Co., Ltd.20240—
+2K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+2K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+2K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+2K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+2K181824CBT Screw Fixation SystemU&I Corporation20180—
+2K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+2K173524ANAX 5.5™ Spinal SystemU&I Corporation201721
+2K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd.20175—
+2K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.20166—
+2K162189ANAX™ 5.5 Spinal SystemU&I Corporation20163—
+2K140219Picasso II Mis Spinal SystemAccel Spine20141—
+3K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+3K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+3K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—