510(k) Report

Devices descending from K841189

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+7K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+7K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+7K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+7K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+7K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+7K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedExactech, Inc.201510—
+7K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+7K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+7K140734Nextgen Altius Oct SystemEbi, LLC20140—
+7K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+7K141791Biomet Fusion SystemBiomet Spine2014128—
+7K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+7K133053Milestone Spinal SystemWeigao Orthopaedic Device Co., Ltd.20142—
+7K132765PFX Spinous Process Fixation SystemInnovasis, Inc.20140—
+7K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+7K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+7K133583Opticage Interbody Fusion Device, Model Series 9070Interventional Spine, Inc.20140—
+7K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+7K132559Monument SpacersGlobus Medical, Inc.2013166—
+7K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+7K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+7K131540Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc.20136—
+7K131071Staxx Ibl SystemSpine Wave, Inc.20138—
+7K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+7K131449Coalition SpacerGlobus Medical, Inc.2013235—
+7K131547Lanx Fusion SystemLanx, Inc.20131631
+7K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+7K130194Acculif XL CageCoalign Innovations, Inc.20131—
+7K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+7K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+7K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+7K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+7K122047Alamo PAlliance Partners, LLC20120—
+7K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+7K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+7K113346Neon SystemUlrich GmbH & Co. KG20121—
+7K113252Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2012306—
+7K112388Lanx Cervical SALanx, Inc.201126—
+7K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+7K111569Plateau Spacer SystemLife Spine2011181—
+7K100945Fuse Plif CafeAdvanced Medical Technologies AG2011463—
+7K100175Clydesdale Spinal SystemMedtronic Sofamor Danek20101,008—
+7K091813Intrepid Spinal SystemMedtronic Sofamor Danek2009719—
+7K082801Phantom Plus Cage SystemUs Spine2008643—
+8K263049SABER-C SystemElevation Spine20260—
+8K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+8K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+8K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+8K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+8K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+8K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+8K243474MagnetOs MISKuros Biosciences B.V20250—
+8K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K243249TriALTIS™ Spine SystemMedos International SARL20250—
+8K243693NEO Pedicle Screw System™Neo Medical SA20240—
+8K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K240160EGPS Navigated InstrumentsAstura Medical20240—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+8K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+8K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+8K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+8K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+8K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+8K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+8K240453ReBOSSISOrthorebirth Co., Ltd.202402
+8K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+8K233300POWEReam 1/4 DriveStryker Instruments20231—
+8K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K231515MySpine Cervical GuidesMedacta International S.A.20230—
+8K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+8K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+8K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K233366SYMPHONY OCT SystemMedos International SARL20230—
+8K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+8K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+8K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+8K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+8K223558CUVIS-spineCurexo, Inc.20230—