510(k) Report

Devices descending from K040536

1,150 later devices reach Modification to Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+11K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+11K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+11K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+11K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+11K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+11K220025ARx® Spinal SystemLife Spine, Inc.20220—
+11K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+11K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+11K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+11K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+11K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+11K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+11K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+11K191575ARx Spinal SystemLife Spine, Inc.201910—
+11K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+11K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+11K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+11K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+11K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+11K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+11K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+11K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+11K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+12K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+12K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+12K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+12K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+12K233256Robotic Integration InstrumentsDePuy Synthes20240—
+12K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+12K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+12K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+12K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+12K200070ARx Spinal SystemLife Spine, Inc.20209—
+12K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+12K171425Concorde LiftMedos International SARL201782
+13K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+13K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+13K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+13K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+13K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+13K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+13K210549ARx Spinal SystemLife Spine, Inc.20211—
+13K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+13K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+13K182349Concorde LiftMedos International SARL20190—
+13K173537Concorde Lift™Medos International SARL20181—
+14K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+14K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+14K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—