510(k) Report

Devices descending from K022015

22 later devices reach Modification to Vertex Reconstruction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062934SierraSeaspine, Inc.200621—
+2K133698Synapse SystemSynthes USA Products, LLC20146—
+2K122163Certex Spinal Implant SystemX-Spine Systems, Inc.20122—
+2K120467Spinal Elements Posterior Cervical/Thoracic Spinal SystemSpinal Elements, Inc.20121—
+2K072729SierraSeaspine, Inc.20085—
+2K080526Sierra SystemSeaspine, Inc.20089—
+3K231654NorthStar OCT SystemSeaspine, Inc.20230—
+3K193615NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation20201—
+3K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+3K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+3K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC20145—
+3K133094Certex Oct Spinal Implant SystemX-Spine Systems, Inc.20131—
+3K131427LOTUSSpinal Elements, Inc.20130—
+3K112025Sure Lok Mini Posterior Cervical/Upper Thoracic SystemSpinal USA20114—
+4K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc.20153—
+4K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC20153—
+5K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC20212—
+5K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+6K223852VySpan™ PCT SystemVy Spine, LLC20231—
+6K172495Reform® POCT SystemPrecision Spine, Inc.20181—
+7K232167VySpan™ PCT SystemVy Spine, LLC20230—
+7K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—