510(k) Report

Devices descending from K181949

10 later devices reach SYMPHONY™ OCT System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+1K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+1K192014SYPMHONY™ OCT SystemMedos International SARL20203—
+1K190895MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT…Medos International SARL20199—
+2K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+2K233366SYMPHONY OCT SystemMedos International SARL20230—
+2K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—