510(k) Report

Devices descending from K150918

13 later devices reach PASS OCT Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+1K161149PASS OCT Spinal SystemMedicrea International SA20160—
+1K160756PASS OCT Spinal SystemMedicrea International SA20160—
+1K153169PASS OCT Patient Specific RodsMedicrea International20164—
+2K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+2K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+2K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+3K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—