510(k) Report

Devices descending from K082572

659 later devices reach Uss Iliosacral, Uss Polyaxial through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+5K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+5K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+5K173117NuVasive® VersaTie™ SystemNuvasive, Inc.20172—
+5K172021LigaPASSMedicrea International SA201711—
+5K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+5K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+5K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+5K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity20177—
+5K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+5K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+5K142798PASS LP Spinal SystemMedicrea International SA201584—
+5K150049PASS LP Spinal SystemMedicrea International20150—
+5K141398Pass LP Spinal SystemMedicrea International SA2015101
+5K140738Pass LP Spinal SystemMedicrea International201447—
+5K132574Pass LP Spinal SystemMedicrea International20130—
+5K132575Pass LP Spinal SystemMedicrea International20130—
+6K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+6K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+6K252322SIros-X SystemGenesys Spine20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240526POWEReam Xia/SerratoStryker Instruments20240—
+6K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20241—
+6K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+6K231658VEOS Spinal Fixation SystemSpineway20230—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+6K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+6K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+6K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+6K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+6K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+6K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SA20222—
+6K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+6K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+6K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+6K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+6K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K202771CD Horizon Spinal SystemMedtronic202021—
+6K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+6K200896Solstice CCILife Spine, Inc.20200—
+6K193129Yukon OCT Spinal SystemK2m, Inc.202001
+6K183381Navigation Enabled InstrumentsStryker20191—
+6K190418NuVasive® VersaTie® SystemNu Vasive, Incorporated20190—
+6K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+6K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+6K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+6K173506LigaPASSMedicrea International SA20189—
+6K160640PASS XS Spinal SystemMedicrea International SA20160—
+6K161627PASS LP Spinal SystemMedicrea International SA20167—
+6K153413PASS LP Spinal SystemMedicrea International SA20160—
+6K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+7K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+7K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+7K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—