510(k) Report

Devices descending from K080699

798 later devices reach Novel Spinal Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+1K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+1K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+1K160646XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc.201641—
+1K143740Battalion Universal Spacer SystemAlphatec Spine, Inc.2015247—
+1K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+1K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+1K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+1K110843Aleutian Spacer SystemK2m, Inc.2011589—
+1K100743Atlas Spine Pivoting SystemAtlas Spine, Inc.20104—
+1K090425Guided Lateral Interbody Fusion (Glif) SystemAlphatec Spine, Inc.2009319—
+2K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+2K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+2K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+2K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+2K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+2K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+2K231359RODIN™ Expandable Lumbar Cage SystemCtl Medical Corporation20230—
+2K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+2K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+2K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+2K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+2K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+2K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+2K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+2K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+2K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+2K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+2K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+2K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+2K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+2K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+2K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+2K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+2K172009Cascadia Interbody SystemK2m, Inc.2017433
+2K172419Velofix™ TLIF CageU&I Corporation20172—
+2K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+2K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+2K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+2K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+2K161379ELSA SpacersGlobus Medical, Inc.2016155—
+2K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+2K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+2K153786Prow Fusion-VNlt Spine, Ltd.20166—
+2K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+2K160547Cascadia Interbody SystemK2m2016157—
+2K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+2K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+2K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+2K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+2K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+2K150481Cascadia Interbody SystemK2m, Inc.20154593
+2K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+2K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+2K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+2K140348Interbody CageEisertech, LLC2015235—
+2K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+2K133614Aleutian Ibf SystemK2m, Inc.2014527—
+2K133126K7 Lumbar SpacersK7, LLC20131—
+2K130699Aleutian Spinal SystemK2m, Inc.2013570—
+2K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+2K112664Zavation Ibf SystemsZavation, LLC201137—
+2K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+3K261049Scala® TLSpineart SA20260—
+3K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+3K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+3K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+3K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+3K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+3K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+3K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+3K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+3K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K240368E3D™-A Interbody SystemEvolution Spine20247—
+3K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K232432E3D™-A Interbody SystemEvolution Spine20248—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+3K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+3K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+3K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+3K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+3K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—