510(k) Report

Devices descending from K043565

834 later devices reach Modification to Dynesys Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+9K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+9K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+9K201585Monterey AL Interbody SystemStryker Corporation202044
+9K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+9K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+9K200896Solstice CCILife Spine, Inc.20200—
+9K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+9K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+9K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+9K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+9K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+9K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+9K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+9K191217Jazz PFImplanet, S.A.20190—
+9K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+9K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+9K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+9K182470Plateau Spacer SystemLife Spine20180—
+9K181188EVEREST Spinal SystemK2m, Inc.20186—
+9K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+9K171881JAZZ Passer BandImplanet, S.A.20170—
+9K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+9K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+9K170647Connector SystemOrthofix, Inc.201718—
+9K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+9K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+9K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+9K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+10K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+10K262094E3D™-C Interbody SystemEvolution Spine20260—
+10K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+10K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+10K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+10K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+10K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+10K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+10K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+10K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+10K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+10K260038E3D™-C Interbody SystemEvolution Spine20261—
+10K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+10K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+10K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+10K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+10K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+10K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+10K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+10K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+10K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+10K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+10K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+10K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+10K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+10K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+10K242042TriALTIS™ Spine SystemMedos International SARL20241—
+10K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+10K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+10K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+10K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+10K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+10K240526POWEReam Xia/SerratoStryker Instruments20240—
+10K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+10K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+10K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+10K232628VADER® Pedicle SystemIcotec AG20241—
+10K232432E3D™-A Interbody SystemEvolution Spine20248—
+10K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+10K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+10K233366SYMPHONY OCT SystemMedos International SARL20230—
+10K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+10K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+10K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+10K230989Rod Registration FrameNu Vasive, Incorporated20230—
+10K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+10K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+10K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+10K223294SpineJack® Expansion KitStryker Instruments20221—
+10K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+10K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+10K222698CUVIS-spineCurexo, Inc.20220—
+10K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+10K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+10K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+10K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+10K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+10K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+10K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+10K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+10K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+10K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+10K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+10K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+10K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+10K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+10K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—