510(k) Report

Devices descending from K161032

7 later devices reach neon3™ universal OCT spinal stabilization through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+1K230614Cortium™Ulrich Medical USA20230—
+1K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+1K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+1K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+2K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+2K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—