510(k) Report

Devices descending from K153169

4 later devices reach PASS OCT Patient Specific Rods through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+1K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+2K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+3K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—