510(k) Report

Devices descending from K001532

997 later devices reach Dyna-Lok Classic Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K170647Connector SystemOrthofix, Inc.201718—
+6K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+6K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+6K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+6K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+6K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+6K162143FixxSure® X-LinkInnovasis, Inc.20160—
+6K160640PASS XS Spinal SystemMedicrea International SA20160—
+6K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+6K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+6K153413PASS LP Spinal SystemMedicrea International SA20160—
+6K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+6K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+6K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+6K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+6K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+6K150417Astra Spine SystemSpinecraft, LLC201521—
+6K142798PASS LP Spinal SystemMedicrea International SA201584—
+6K150049PASS LP Spinal SystemMedicrea International20150—
+6K140738Pass LP Spinal SystemMedicrea International201447—
+6K132765PFX Spinous Process Fixation SystemInnovasis, Inc.20140—
+6K133369Tiger Spine SystemCorelink, LLC201429—
+6K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+6K132603Apex Spine SystemSpinecraft, LLC201325—
+6K132574Pass LP Spinal SystemMedicrea International20130—
+6K132575Pass LP Spinal SystemMedicrea International20130—
+6K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+6K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+6K131250Tiger Spine SystemCorelink, LLC201340—
+6K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+6K131343Reform Pedicle Screw SystemSpinal USA201331—
+6K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+6K130279Reform Pedicle Screw SystemSpinal USA201331—
+6K131030Range Spinal SystemK2m, Inc.201334—
+6K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+6K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+6K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+6K121568Dali Spinal Fixation SystemAccel Spine20121—
+6K112607Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20125—
+6K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+6K110906Apex Spine SystemSpinecraft, LLC2011103—
+6K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+6K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+6K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+7K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+7K261408SABER-XA SystemElevation Spine20260—
+7K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+7K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+7K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+7K252742Navigated InstrumentsTyber Medical, LLC20251—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+7K250637VCFix Spinal SystemAmber Implants20250—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+7K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+7K232628VADER® Pedicle SystemIcotec AG20241—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K233300POWEReam 1/4 DriveStryker Instruments20231—
+7K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+7K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+7K233366SYMPHONY OCT SystemMedos International SARL20230—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+7K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+7K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+7K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+7K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+7K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+7K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—