510(k) Report

Devices descending from K150135

228 later devices reach DIVERGENCE-L Anterior/Oblique Lumbar Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261408SABER-XA SystemElevation Spine20260—
+1K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+1K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+1K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+1K172083Idys™ ALIF SystemClariance, Sas20177—
+1K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+1K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+1K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+1K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+1K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+1K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+2K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+2K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+2K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+2K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+2K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+2K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+2K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+2K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+2K201671A-Link ZAcuity Surgical Devices, LLC202125—
+2K200919Idys ALIF 3DTiClariance20210—
+2K202032Idys LLIF 3DTiClariance, Sas20210—
+2K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+2K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+2K191134IB3D AlifMedicrea International SA20191—
+2K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+2K191263Idys ALIF TiVacClariance, Sas20190—
+2K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+2K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+2K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+3K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+3K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+3K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+3K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+3K223326Axiom PSR SystemRestor3D202301
+3K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+3K222561AlignAcuity Surgical Devices, LLC202214—
+3K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+3K220610SOLO-LAurora Spine, Inc.20220—
+3K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+3K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+3K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+3K212562Idys-C ZP 3DTiClariance, SA20211—
+3K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K200316UNiD IB3D ALIFMedicrea International SA20200—
+3K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K181397DualXInnovasive, Inc.201815—
+3K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+3K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+4K252742Navigated InstrumentsTyber Medical, LLC20251—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+4K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+4K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+4K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K240715Idys® C ZP 3DTiClariance20240—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K232432E3D™-A Interbody SystemEvolution Spine20248—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+4K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+4K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+4K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+4K211740DualXAmplify Surgical, Inc.20211—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—