510(k) Report

Devices descending from K041888

1,586 later devices reach Curved Peek Tetris Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K161129Pillar SA PTCOrthofix, Inc.201619—
+4K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+4K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+4K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+4K160995NEOVIEW Plating SystemIn2bones Sas201624
+4K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+4K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+4K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+4K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+4K160125Cascadia Interbody SystemK2m2016315—
+4K153413PASS LP Spinal SystemMedicrea International SA20160—
+4K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+4K160547Cascadia Interbody SystemK2m2016157—
+4K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+4K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+4K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+4K150481Cascadia Interbody SystemK2m, Inc.20154593
+4K150847Foundation Interbody DevicesCorelink, LLC201529—
+4K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+4K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+4K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedExactech, Inc.201510—
+4K142487Chesapeake Stabilization SystemK2m, Inc.201571
+4K142744Mecta-C TiPEEKMedacta International201512—
+4K140348Interbody CageEisertech, LLC2015235—
+4K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+4K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+4K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+4K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+4K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+4K133827A-Link ZOsteo Vasive, LLC2014262
+4K141942Midline II TICentinel Spine, Inc.2014459—
+4K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+4K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+4K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+4K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+4K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+4K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+4K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+4K132738Cogent Med-LifCogent Spine, LLC201413—
+4K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+4K132596Proposed OptimusCustom Spine, Inc.201451
+4K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+4K133614Aleutian Ibf SystemK2m, Inc.2014527—
+4K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+4K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+4K133967Interbody Cage SystemAurora Spine2014227—
+4K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+4K133286Midline (TM)Centinel Spine, Inc.2014460—
+4K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+4K130254Prow FusionNlt Spine, Ltd.20138—
+4K131178Idys Lif CagesClariance201311—
+4K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+4K130461Stalif XCentinel Spine, Inc.201313—
+4K130820Expandable Lumbar Interbody SystemNu Vasive, Incorporated2013593—
+4K131077Life Spine Plateau Spacer SystemLife Spine201310—
+4K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+4K130699Aleutian Spinal SystemK2m, Inc.2013570—
+4K124034Mectalif AnteriorMedacta International201311—
+4K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+4K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+4K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+4K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+4K123388K7C SpacerK7, LLC20130—
+4K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+4K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+4K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+4K122444Cervical CageEisertech, LLC201222—
+4K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+4K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+4K113138Aleutian SystemK2m, Inc.2012549—
+4K112664Zavation Ibf SystemsZavation, LLC201137—
+4K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+4K103169AleuttianK2m, Inc.2011572—
+4K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant…Omni Surgical, L.P.20116—
+4K100037Advanced Vertebral Solutions Express BFDAdvanced Vertebral Solutions, LLC20100—
+4K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine201016—
+4K101302Aleutian Ibf SystemK2m, Inc.2010595—
+4K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+4K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+4K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751
+4K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008840—
+4K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.20081,103—
+4K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+4K073502Vertebron VBR SystemVertebron, Inc.200812—
+5K261049Scala® TLSpineart SA20260—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+5K2530413d Cage CervicalFims Co., Ltd.20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+5K261067BEE PLIF CageNGMedical GmbH20260—
+5K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+5K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+5K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+5K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+5K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—