510(k) Report

Devices descending from K160731

6 later devices reach LumFix Spinal Fixation Sytem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+1K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+1K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+1K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+2K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+2K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—