510(k) Report

Devices descending from K080758

1,091 later devices reach Avs PL Peek Spacers, Models 48351 and 48353 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+4K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+4K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+4K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+4K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+4K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+4K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+4K162496Foundation 3D InterbodyCorelink, LLC201782—
+4K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+4K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+4K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+4K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+4K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+4K162262Tritanium® PL CageStryker2016132—
+4K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+4K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+4K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+4K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+4K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+4K160955Tritanium® PL CageStryker2016178—
+4K153621Juliet® TiSpineart2016751
+4K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+4K152622Alta ACDF SystemBiomet Spine20160—
+4K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+4K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+4K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+4K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K160125Cascadia Interbody SystemK2m2016315—
+4K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+4K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+4K151481Sahara Stabilization SystemK2m, Inc.20155—
+4K152651AccuLIF TL and PL CageStryker Corporation201530—
+4K143479Bluefin Interbody SystemTides Medical20152—
+4K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+4K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+4K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+4K142487Chesapeake Stabilization SystemK2m, Inc.201571
+4K141798Sypher Spacer SystemBiogennix, LLC20151—
+4K141942Midline II TICentinel Spine, Inc.2014459—
+4K133717Longbow Spacer SystemLife Spine20149—
+4K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+4K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+4K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+4K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+4K133286Midline (TM)Centinel Spine, Inc.2014460—
+4K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+4K124034Mectalif AnteriorMedacta International201311—
+4K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+4K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+4K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+4K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+4K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+4K111983Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology201131—
+4K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+4K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+4K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+4K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+5K261430TruLift Expandable SystemLife Spine, Inc.20260—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K242303MOD-COrthomod, LLC20260—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+5K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+5K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+5K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+5K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+5K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+5K242589Scarlet® AL-TSpineart SA20240—
+5K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—