510(k) Report

Devices descending from K841189

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+9K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+9K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+9K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+9K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+9K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+9K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+9K242042TriALTIS™ Spine SystemMedos International SARL20241—
+9K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+9K233256Robotic Integration InstrumentsDePuy Synthes20240—
+9K240526POWEReam Xia/SerratoStryker Instruments20240—
+9K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+9K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+9K230989Rod Registration FrameNu Vasive, Incorporated20230—
+9K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+9K222789VADER® Pedicle System, G21 CementIcotec AG202352
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K223294SpineJack® Expansion KitStryker Instruments20221—
+9K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+9K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+9K222698CUVIS-spineCurexo, Inc.20220—
+9K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+9K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+9K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+9K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+9K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+9K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206—
+9K193129Yukon OCT Spinal SystemK2m, Inc.202001
+9K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+9K182721Choice Spine Navigation SystemChoicespine, LP20192—
+9K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+9K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+9K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+9K180437Hexanium® TLIFSpinevision, S.A.S.20182—
+9K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+9K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+9K172194Connector SystemOrthofix, Inc.2017162
+9K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+9K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+9K161149PASS OCT Spinal SystemMedicrea International SA20160—
+9K160756PASS OCT Spinal SystemMedicrea International SA20160—
+9K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+9K153169PASS OCT Patient Specific RodsMedicrea International20164—
+9K152211PCT SystemCentinel Spine, Inc.20150—
+9K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+9K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp.20145—
+9K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+10K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+10K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+10K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+10K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+10K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+10K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+10K250637VCFix Spinal SystemAmber Implants20250—
+10K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+10K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+10K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+10K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+10K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+10K232628VADER® Pedicle SystemIcotec AG20241—
+10K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+10K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+10K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+10K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+10K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+10K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+10K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+10K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+10K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+10K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+10K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+10K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+10K190751Connector SystemOrthofix, Inc.20193—
+10K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+10K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+10K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+11K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+11K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+11K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+11K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+11K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+11K241895Cannulated PsiFGuardSpineguard20240—
+11K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+11K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+11K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+11K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+11K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+11K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+11K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+11K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+11K213815SiJoin®T3Vgi Medical, Inc.20230—
+11K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—