510(k) Report

Devices descending from K946173

155 later devices reach Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+5K221412ARIX Rib SystemJeil Medical Corporation20221—
+5K172742AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)AtriCure, Inc.20170—
+5K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation20168—
+5K160454AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.201602
+5K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc.201610—
+5K143092Tensyn PlugDallen Medical, Inc.20151—
+5K093661ColonringNiti Surgical Solutions, Ltd.20110—
+5K090872Modification to Cardica C-Port XA Distal Anastomosis SystemCardica, Inc.200911
+5K073304Cardica C-Port X-Change Anastomosis System and Handle and XA X-Change SubassembliesCardica, Inc.20070—
+5K070548C-Port Flexa Distal Anastomosis SystemCardica, Inc.200711
+5K062008Endo Car Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd.20061—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K253660KLS Martin Pure Pectus SystemKLS-Martin L.P.20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K253550Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc.20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20252—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K212608RibFix Blu Thoracic Fixation SystemBiomet Microfixation20224—
+6K190409MatrixRIB Fixation SystemDePuy Synthes20193—
+6K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc.20179—
+6K150359Tensyn PlugDallen Medical, Inc.20150—
+6K101018Cardica C-Port XA Plus Distal Anastomosis System, Model FG-000100Cardica, Inc.201001
+6K073123Cardica C-Port Flex-a Distal Anastomosis System, Model FG-000150Cardica, Inc.200701
+7K261054RibPlate SystemStryker Leibinger GmbH & Co KG20260—
+7K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20260—
+7K252166RIB LINK™ Fixation SystemGlobus Medical, Inc.20260—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20251—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K241282RibFix Titan™ Fixation SystemRiverpoint Medical20240—
+7K190963DePuy Synthes Craniomaxillofacial Sternal Devices - MR ConditionalSynthes (USA) Products, LLC20190—
+7K180010AtriClip FLEX-VAtriCure, Inc.20188—
+8K181474ArtiClip LAA Exclusion SystemAtriCure, Inc.20187—
+9K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA…AtriCure, Inc.20196—
+10K210293AtriClip LAA Exclusion SystemAtriCure, Inc.20215—
+11K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage…Edwards Lifesciences20260—
+11K233407AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA…AtriCure, Inc.20231—
+11K220305Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSyntheon20222—
+12K252917ATLAAS (Atraumatic Left Atrial Appendage System) (AD)Genesee Biomedical, Inc.20260—
+12K232295LAA Exclusion SystemSyntheon, LLC20231—