510(k) Report

Devices descending from K162189

3 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—
+1K173524ANAX 5.5™ Spinal SystemU&I Corporation201721