510(k) Report

Devices descending from K100089

797 later devices reach Synthes T-Pal Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+3K201287Impulse Interbody Fusion SystemDegen Medical20208—
+3K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+3K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+3K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+3K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K192897icotec Cervical CageIcotec AG20201—
+3K193521Steerable Plateau TiLife Spine, Inc.20201—
+3K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+3K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+3K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+3K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+3K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+3K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K181397DualXInnovasive, Inc.201815—
+3K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+3K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+3K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+3K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+3K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+3K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+3K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+3K172941CASCADIA Interbody SystemK2m201852—
+3K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+3K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+3K172009Cascadia Interbody SystemK2m, Inc.2017433
+3K172419Velofix™ TLIF CageU&I Corporation20172—
+3K172424Velofix™ SA Cervical CageU&I Corporation201751
+3K163595IMPIX 3D Print CagesMedicrea International SA2017282
+3K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+3K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+3K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+3K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+3K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+3K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+3K170055CAPRI Corpectomy Cage SystemK2m201711—
+3K162206Zavation IBFZavation, LLC201724—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K163364MOJAVE Expandable Interbody SystemK2m201725—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K162264Cascadia Interbody SystemK2m, Inc.2016169—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K153621Juliet® TiSpineart2016751
+3K153786Prow Fusion-VNlt Spine, Ltd.20166—
+3K160125Cascadia Interbody SystemK2m2016315—
+3K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K160547Cascadia Interbody SystemK2m2016157—
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+3K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+3K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+3K151756Sterispine LC CageSafe Orthopaedics20150—
+3K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+3K142392Zavation Posterior LEIFZavation, LLC20150—
+3K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+3K142271Zavation Z-Link LumbarZavation, LLC20149—
+3K141005Z-Link CervicalZavation, LLC20144—
+3K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+3K133893Sterispine LC CageSafe Orthopaedics20141—
+3K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+4K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+4K261049Scala® TLSpineart SA20260—
+4K261430TruLift Expandable SystemLife Spine, Inc.20260—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+4K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+4K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+4K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+4K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+4K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+4K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+4K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—