510(k) Report

Devices descending from K030601

1,151 later devices reach Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+11K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+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—
+11K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+11K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+12K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+12K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+12K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+12K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+12K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+12K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+12K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+12K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+12K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+12K220025ARx® Spinal SystemLife Spine, Inc.20220—
+12K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+12K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+12K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+12K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+12K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+12K191575ARx Spinal SystemLife Spine, Inc.201910—
+12K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+12K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+12K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+12K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+12K171425Concorde LiftMedos International SARL201782
+13K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+13K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+13K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+13K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+13K233256Robotic Integration InstrumentsDePuy Synthes20240—
+13K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+13K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+13K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+13K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+13K200070ARx Spinal SystemLife Spine, Inc.20209—
+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—
+14K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+14K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+14K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+14K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+14K210549ARx Spinal SystemLife Spine, Inc.20211—
+14K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+14K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+15K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+15K230880CoreLink Navigation InstrumentsCorelink, LLC20230—