510(k) Report

Devices descending from P950019

1,482 later devices reach Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+6K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+6K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+6K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+6K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+6K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+6K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+6K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+6K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+6K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+6K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+6K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+6K232315Catalyst Bone Void FillerOssdsign AB20237—
+6K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+6K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+6K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+6K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+6K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+6K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+6K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+6K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+6K213815SiJoin®T3Vgi Medical, Inc.20230—
+6K230026SqualeImplanet, S.A.20230—
+6K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+6K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+6K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+6K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+6K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+6K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+6K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+6K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+6K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+6K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+6K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+6K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+6K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+6K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+6K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+6K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+6K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+6K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+6K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+6K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+6K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+6K210728CONDUIT InstrumentsMedos International SARL20215—
+6K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+6K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+6K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+6K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+6K202637F3D Corpectomy SystemCorelink, LLC20201—
+6K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+6K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+6K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+6K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+6K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+6K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+6K193258ProLift Expandable SystemLife Spine, Inc.20203—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+6K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+6K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+6K183064TxTi IBF SystemInnovasis, Inc.2019481
+6K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+6K182608Oyster ACIF CageSilony Medical GmbH20190—
+6K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+6K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+6K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+6K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+6K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+6K182584Lucent® XPSpinal Elements, Inc.20183—
+6K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+6K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+6K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+6K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+6K181014Tritanium PL CageStryker Spine2018137—
+6K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—