510(k) Report

Devices descending from K060350

754 later devices reach Construx PL/TL Peek Partial VBR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K243188Cylox® STSignus Medizintechnik GmbH20250—
+9K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K234150Lucent® XPSpinal Elements20240—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K223418DeGen Impulse AM™ SystemDegen Medical20236—
+9K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+9K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+9K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+9K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+9K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+9K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+9K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+9K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+9K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+9K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+9K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+9K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+9K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+9K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+9K183243Velofix TLIF CageU&I Corporation20190—
+9K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+9K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+9K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+9K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+9K181829Velofix TLIF CageU&I Corporation20181—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+10K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+10K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+10K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+10K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+10K202637F3D Corpectomy SystemCorelink, LLC20201—
+10K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+10K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+10K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+10K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+10K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+11K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+11K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+11K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+11K221578Hexanium ACIFSpinevision, S.A.S.20224—
+11K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—