510(k) Report

Devices descending from K980288

959 later devices reach Spine-Tech Silhouette Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+7K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc.2012151
+7K113346Neon SystemUlrich GmbH & Co. KG20121—
+7K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+8K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+8K261408SABER-XA SystemElevation Spine20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K260810Anteralign LS coverplateTyber Medical, LLC20260—
+8K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+8K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K252742Navigated InstrumentsTyber Medical, LLC20251—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+8K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+8K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+8K243249TriALTIS™ Spine SystemMedos International SARL20250—
+8K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+8K243693NEO Pedicle Screw System™Neo Medical SA20240—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K240160EGPS Navigated InstrumentsAstura Medical20240—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+8K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+8K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K233300POWEReam 1/4 DriveStryker Instruments20231—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K233366SYMPHONY OCT SystemMedos International SARL20230—
+8K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+8K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+8K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+8K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+8K223558CUVIS-spineCurexo, Inc.20230—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+8K230614Cortium™Ulrich Medical USA20230—
+8K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+8K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+8K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+8K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+8K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+8K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+8K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+8K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+8K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+8K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+8K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+8K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+8K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+8K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+8K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+8K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K211740DualXAmplify Surgical, Inc.20211—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+8K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+8K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+8K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+8K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+8K201569CUVIS-spineCurexo, Inc.20212—
+8K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+8K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+8K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+8K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+8K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+8K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+8K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+8K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+8K200896Solstice CCILife Spine, Inc.20200—
+8K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+8K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+8K191217Jazz PFImplanet, S.A.20190—
+8K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+8K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+8K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+8K182182YUKON OCT Spinal SystemK2m20185—