510(k) Report

Devices descending from K163375

16 later devices reach INFINITY™ OCT System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+1K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+1K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+1K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+1K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+1K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+1K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+2K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+2K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+2K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+2K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K233366SYMPHONY OCT SystemMedos International SARL20230—
+3K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—