510(k) Report

Devices descending from K090566

639 later devices reach Pathway Avid through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+4K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+4K172009Cascadia Interbody SystemK2m, Inc.2017433
+4K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+4K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+4K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+4K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+4K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+4K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+4K161379ELSA SpacersGlobus Medical, Inc.2016155—
+4K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+4K153786Prow Fusion-VNlt Spine, Ltd.20166—
+4K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+4K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+4K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+4K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+4K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+4K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+4K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+4K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+5K261049Scala® TLSpineart SA20260—
+5K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+5K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+5K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+5K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+5K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+5K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+5K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+5K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+5K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+5K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+5K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+5K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+5K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+5K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+5K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+5K221172FOCUS Interbody SystemOc Medical Devices20220—
+5K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+5K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+5K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+5K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+5K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+5K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+5K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+5K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+5K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+5K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+5K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+5K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+5K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+5K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+5K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+5K201585Monterey AL Interbody SystemStryker Corporation202044
+5K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+5K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+5K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+5K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+5K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+5K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+5K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+5K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+5K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+5K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+5K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+5K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+5K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+5K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+5K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+5K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+5K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+5K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+5K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+5K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+5K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+5K162496Foundation 3D InterbodyCorelink, LLC201782—
+5K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+5K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—