510(k) Report

Devices descending from K022793

1,705 later devices reach Tetris Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K140303Alamo TAlliance Partners, LLC20140—
+5K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+5K132738Cogent Med-LifCogent Spine, LLC201413—
+5K133614Aleutian Ibf SystemK2m, Inc.2014527—
+5K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+5K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+5K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+5K133967Interbody Cage SystemAurora Spine2014227—
+5K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+5K132757Everest Spinal SystemK2m, Inc.201341—
+5K130853Idys (TM) CClariance20132—
+5K131178Idys Lif CagesClariance201311—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+5K131671MectalifMedacta International201322—
+5K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+5K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+5K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+5K130434Octane Straight, Octane Straight - Lordotic, Octane Straight I/R, Octane Straight I/R -…Exactech, Inc.201311—
+5K130306Incite Anchored Cervical Interbody DeviceIncite Innovation, LLC20131—
+5K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+5K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+5K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+5K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+5K120603Varilift -CWenzel Spine2013193—
+5K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+5K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+5K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+5K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+5K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+5K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+5K122021Sterispine LC CageSafe Orthopaedics20122—
+5K120819Stalif CCentinel Spine, Inc.2012206—
+5K122444Cervical CageEisertech, LLC201222—
+5K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+5K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+5K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+5K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+5K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+5K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+5K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+5K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+5K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+5K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+5K110843Aleutian Spacer SystemK2m, Inc.2011589—
+5K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+5K082698Aleutian Ibf SystemK2m, Inc.2009662—
+5K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+5K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.20071,405—
+5K063399Aleutian Spacer SystemK2m, Inc.2007663—
+5K060350Construx PL/TL Peek Partial VBR SystemBlackstone Medical, Inc.2006754—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+6K2530413d Cage CervicalFims Co., Ltd.20260—
+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—
+6K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+6K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K261067BEE PLIF CageNGMedical GmbH20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K242303MOD-COrthomod, LLC20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+6K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+6K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K243670Idys® LIFClariance20240—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+6K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+6K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+6K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+6K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+6K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+6K240699SCARLET® AC-TiSpineart SA20240—