510(k) Report

Devices descending from K033312

277 later devices reach Ebi Top Loading Mas Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+4K183092Kuros TLIF CageKuros Biosciences B.V20190—
+4K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+4K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+4K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+4K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K132603Apex Spine SystemSpinecraft, LLC201325—
+4K123373Nautilus Spinal SystemLife Spine201317—
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K111953Nautilus Spinal SystemLife Spine20123—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+5K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+5K232628VADER® Pedicle SystemIcotec AG20241—
+5K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+5K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+5K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+5K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+5K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+5K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+5K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+5K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K150417Astra Spine SystemSpinecraft, LLC201521—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+5K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—