510(k) Report

Devices descending from K132101

13 later devices reach Anax 5.5 Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233960INNOVERSE Spinal SystemInnosys Co., Ltd.20240—
+1K231737ANAX™ 5.5 Spinal SystemInnosys Co., Ltd.20231—
+1K181824CBT Screw Fixation SystemU&I Corporation20180—
+1K173524ANAX 5.5™ Spinal SystemU&I Corporation201721
+1K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.20166—
+1K162189ANAX™ 5.5 Spinal SystemU&I Corporation20163—
+1K143417ANAX 5.5 Spinal SystemU&I Corporation20154—
+2K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+2K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+2K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+2K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+3K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—