510(k) Report

Devices descending from K210449

3 later devices reach Infinity™ OCT System, PASS OCT® Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+1K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+2K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—