510(k) Report

Devices descending from K841189

2,425 later devices reach Oec/Rezaian Spinal Fixator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K242589Scarlet® AL-TSpineart SA20240—
+6K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+6K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+6K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+6K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+6K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+6K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+6K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+6K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+6K240368E3D™-A Interbody SystemEvolution Spine20247—
+6K240699SCARLET® AC-TiSpineart SA20240—
+6K240392JAZZ Spinal SystemImplanet20241—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+6K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+6K240715Idys® C ZP 3DTiClariance20240—
+6K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+6K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+6K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+6K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+6K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+6K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+6K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+6K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+6K231658VEOS Spinal Fixation SystemSpineway20230—
+6K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+6K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+6K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+6K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+6K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+6K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+6K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+6K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+6K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+6K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+6K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+6K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+6K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+6K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+6K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+6K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+6K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+6K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+6K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+6K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+6K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+6K231359RODIN™ Expandable Lumbar Cage SystemCtl Medical Corporation20230—
+6K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+6K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+6K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+6K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K230026SqualeImplanet, S.A.20230—
+6K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+6K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+6K230583Tryptik TiSpineart SA20231—
+6K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+6K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+6K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+6K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+6K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+6K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+6K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+6K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+6K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—