510(k) Report

Devices descending from K031757

1,702 later devices reach Peek Tetris Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K130699Aleutian Spinal SystemK2m, Inc.2013570—
+5K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+5K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+5K130306Incite Anchored Cervical Interbody DeviceIncite Innovation, LLC20131—
+5K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+5K120603Varilift -CWenzel Spine2013193—
+5K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+5K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+5K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+5K122021Sterispine LC CageSafe Orthopaedics20122—
+5K120819Stalif CCentinel Spine, Inc.2012206—
+5K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+5K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+5K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+5K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+5K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+5K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+5K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+5K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+5K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+5K103169AleuttianK2m, Inc.2011572—
+5K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant…Omni Surgical, L.P.20116—
+5K100037Advanced Vertebral Solutions Express BFDAdvanced Vertebral Solutions, LLC20100—
+5K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine201016—
+5K101302Aleutian Ibf SystemK2m, Inc.2010595—
+5K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+5K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+5K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751
+5K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008840—
+5K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.20081,103—
+5K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+5K073502Vertebron VBR SystemVertebron, Inc.200812—
+6K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261049Scala® TLSpineart SA20260—
+6K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+6K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+6K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+6K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K242303MOD-COrthomod, LLC20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K250560BEE HANGMedical GmbH20250—
+6K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+6K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+6K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+6K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+6K242589Scarlet® AL-TSpineart SA20240—
+6K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+6K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+6K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+6K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+6K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+6K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K240699SCARLET® AC-TiSpineart SA20240—
+6K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+6K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+6K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+6K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+6K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—