510(k) Report

Devices descending from K030744

1,040 later devices reach Blackstone Surgical Titanium Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+6K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+6K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+6K182470Plateau Spacer SystemLife Spine20180—
+6K181963ostaPek Interbody Fusion CagesColigne AG20181—
+6K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+6K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+6K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+6K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+6K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+6K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+6K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+6K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+6K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+6K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+6K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+6K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+6K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+6K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+6K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+6K172009Cascadia Interbody SystemK2m, Inc.2017433
+6K170235Lucent®Spinal Elements, Inc.2017107—
+6K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+6K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+6K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+6K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+6K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+6K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+6K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+6K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+6K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+6K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+6K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+6K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+6K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+6K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+6K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+6K163364MOJAVE Expandable Interbody SystemK2m201725—
+6K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+6K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+6K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+6K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+6K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+6K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+6K161379ELSA SpacersGlobus Medical, Inc.2016155—
+6K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+6K153786Prow Fusion-VNlt Spine, Ltd.20166—
+6K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+6K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+6K160125Cascadia Interbody SystemK2m2016315—
+6K160547Cascadia Interbody SystemK2m2016157—
+6K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+6K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+6K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+6K151481Sahara Stabilization SystemK2m, Inc.20155—
+6K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+6K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+6K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+6K150481Cascadia Interbody SystemK2m, Inc.20154593
+6K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+6K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+6K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+6K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+6K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+6K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+6K141135Juliet LLSpineart2014146—
+6K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+6K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+6K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+6K132738Cogent Med-LifCogent Spine, LLC201413—
+6K133614Aleutian Ibf SystemK2m, Inc.2014527—
+6K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+6K133126K7 Lumbar SpacersK7, LLC20131—
+6K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+6K131178Idys Lif CagesClariance201311—
+6K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+6K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+6K130699Aleutian Spinal SystemK2m, Inc.2013570—
+6K123388K7C SpacerK7, LLC20130—
+6K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+6K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+6K113138Aleutian SystemK2m, Inc.2012549—
+6K112664Zavation Ibf SystemsZavation, LLC201137—
+6K103169AleuttianK2m, Inc.2011572—
+6K101302Aleutian Ibf SystemK2m, Inc.2010595—
+7K263049SABER-C SystemElevation Spine20260—
+7K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+7K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+7K261049Scala® TLSpineart SA20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+7K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+7K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K260660SABER-C SystemElevation Spine20261—
+7K253260ORIO-3D Cage SystemSpineCraft20260—
+7K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—