510(k) Report

Devices descending from K963045

662 later devices reach Synthes (U.S.a.) Universal Sacral System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+6K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+6K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+6K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+6K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+6K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+6K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+6K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+6K191217Jazz PFImplanet, S.A.20190—
+6K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+6K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+6K190751Connector SystemOrthofix, Inc.20193—
+6K182182YUKON OCT Spinal SystemK2m20185—
+6K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+6K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+6K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+6K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+6K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+6K173117NuVasive® VersaTie™ SystemNuvasive, Inc.20172—
+6K172021LigaPASSMedicrea International SA201711—
+6K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+6K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+6K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity20177—
+6K142798PASS LP Spinal SystemMedicrea International SA201584—
+6K150049PASS LP Spinal SystemMedicrea International20150—
+6K141398Pass LP Spinal SystemMedicrea International SA2015101
+6K140738Pass LP Spinal SystemMedicrea International201447—
+6K132574Pass LP Spinal SystemMedicrea International20130—
+6K132575Pass LP Spinal SystemMedicrea International20130—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+7K252322SIros-X SystemGenesys Spine20250—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K243249TriALTIS™ Spine SystemMedos International SARL20250—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20241—
+7K233684TriALTIS™ Spine SystemMedos International SARL20234—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K231658VEOS Spinal Fixation SystemSpineway20230—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+7K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+7K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+7K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+7K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+7K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+7K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+7K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SA20222—
+7K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+7K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+7K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+7K202771CD Horizon Spinal SystemMedtronic202021—
+7K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+7K200896Solstice CCILife Spine, Inc.20200—
+7K193129Yukon OCT Spinal SystemK2m, Inc.202001
+7K183381Navigation Enabled InstrumentsStryker20191—
+7K190418NuVasive® VersaTie® SystemNu Vasive, Incorporated20190—
+7K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+7K173506LigaPASSMedicrea International SA20189—
+7K160640PASS XS Spinal SystemMedicrea International SA20160—
+7K161627PASS LP Spinal SystemMedicrea International SA20167—
+7K153413PASS LP Spinal SystemMedicrea International SA20160—
+7K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—