510(k) Report

Devices descending from K080411

764 later devices reach Plateau Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213417Ghost Spacer SystemLife Spine, Inc.20220—
+1K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+1K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+1K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+1K193521Steerable Plateau TiLife Spine, Inc.20201—
+1K190488ProLift Expandable SystemLife Spine, Inc.201916—
+1K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+1K181625Life Spine Resolute™ Threaded Cage SystemLife Spine, Inc.20180—
+1K182470Plateau Spacer SystemLife Spine20180—
+1K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+1K130630Plateau Spacer System TitaniumLife Spine, Inc.201317—
+1K121116Plateau Spacer SystemLife Spine201213—
+1K111569Plateau Spacer SystemLife Spine2011181—
+1K100865Ava Navigator Peek Spacers, Model 48392XXX, 48393XXXStryker Spine2010637—
+1K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+2K261430TruLift Expandable SystemLife Spine, Inc.20260—
+2K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+2K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+2K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+2K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+2K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+2K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+2K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+2K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+2K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+2K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+2K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+2K193258ProLift Expandable SystemLife Spine, Inc.20203—
+2K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+2K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+2K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+2K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+2K133827A-Link ZOsteo Vasive, LLC2014262
+2K140303Alamo TAlliance Partners, LLC20140—
+2K131077Life Spine Plateau Spacer SystemLife Spine201310—
+2K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated2012172—
+2K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+2K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+3K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+3K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+3K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+3K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+3K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+3K190721LongBow TiLife Spine, Inc.20190—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K181829Velofix TLIF CageU&I Corporation20181—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K172816TiGer Shark™ SystemChoicespine, LP201859—
+3K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+3K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+3K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+3K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+3K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+3K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+3K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+3K152304Tritanium PL CageStryker20154481
+3K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+3K143616AccuLIF TL and PL CageStryker Corporation20154694
+3K133717Longbow Spacer SystemLife Spine20149—
+3K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+4K261049Scala® TLSpineart SA20260—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+4K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+4K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+4K222561AlignAcuity Surgical Devices, LLC202214—
+4K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+4K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+4K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+4K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—