510(k) Report

Devices descending from K000319

700 later devices reach Ebi Xfix DFS System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+7K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+7K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+7K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+7K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+7K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+7K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+7K201287Impulse Interbody Fusion SystemDegen Medical20208—
+7K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+7K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+7K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+7K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—
+7K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+7K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+7K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+7K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+7K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+7K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+7K181188EVEREST Spinal SystemK2m, Inc.20186—
+7K172115Navigated Instrument SystemOrthofix, Inc.20184—
+7K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+7K172469TiLock Modular Spinal SystemGenesys Spine20170—
+7K171321K2M Navigation InstrumentsK2m201711
+7K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+7K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+7K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+7K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K170647Connector SystemOrthofix, Inc.201718—
+7K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+7K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+7K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+7K153413PASS LP Spinal SystemMedicrea International SA20160—
+7K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+7K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+7K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+7K142360Everest Spinal SystemK2m, Inc.201522—
+7K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+7K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+7K123138Pass LP Spinal SystemMedicrea International2013132—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+8K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+8K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+8K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+8K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K240368E3D™-A Interbody SystemEvolution Spine20247—
+8K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+8K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+8K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+8K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+8K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+8K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+8K223418DeGen Impulse AM™ SystemDegen Medical20236—
+8K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+8K213417Ghost Spacer SystemLife Spine, Inc.20220—
+8K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+8K212358Romero Cervical CageSpineup, Inc.20226—
+8K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+8K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+8K201006K2M Navigation InstrumentsK2m, Inc.20200—
+8K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+8K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+8K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+8K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+8K182470Plateau Spacer SystemLife Spine20180—
+8K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+8K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+8K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+8K172194Connector SystemOrthofix, Inc.2017162
+8K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—