510(k) Report

Devices descending from K100043

744 later devices reach Coroent XLR Standalone System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+7K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+7K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+7K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+7K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+7K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+7K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+7K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+7K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+7K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+7K183243Velofix TLIF CageU&I Corporation20190—
+7K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+7K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+7K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+7K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+7K181829Velofix TLIF CageU&I Corporation20181—
+8K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+8K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+8K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+8K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+8K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+8K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+8K202637F3D Corpectomy SystemCorelink, LLC20201—
+8K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+8K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+8K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+8K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+8K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+9K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+9K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+9K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+9K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+9K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+9K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+9K221578Hexanium ACIFSpinevision, S.A.S.20224—
+9K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+10K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—