510(k) Report

Devices descending from K022793

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+4K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+4K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+4K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC20234—
+4K223043The Integrity Spine Core SystemIntegrity Spine20230—
+4K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+4K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine20235—
+4K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+4K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+4K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+4K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+4K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+4K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+4K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+4K190544XIHPOS™ ZFUZE™ Interbody Fusion SystemDifusion Technologies20190—
+4K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+4K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+4K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+4K191778Omnia Medical VBROmnia Medical, LLC20195—
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+4K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+4K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+4K182477Cervical SpacerAdditive Implants, LLC201915—
+4K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+4K181818Scarlet AL-TSpineart201864—
+4K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+4K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+4K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+4K172480icotec Interbody Cage SystemIcotec AG20185—
+4K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+4K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+4K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+4K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+4K173148ACIFColigne AG20171—
+4K173022SeaSpine Ventura NanoMetalene SystemSeaSpine Orthopedics Corporation20170—
+4K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+4K171704CAPRI Corpectomy Cage SystemK2m201710—
+4K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+4K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+4K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+4K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+4K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine20171—
+4K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K162206Zavation IBFZavation, LLC201724—
+4K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+4K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+4K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+4K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+4K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC20160—
+4K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+4K162715SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura…SeaSpine Orthopedics Corporation2016103—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—
+4K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+4K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+4K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+4K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+4K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+4K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+4K160324Cervical Interbody Fusion SystemEvolution Spine, LLC20162—
+4K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+4K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+4K153413PASS LP Spinal SystemMedicrea International SA20160—
+4K151481Sahara Stabilization SystemK2m, Inc.20155—
+4K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+4K151819Integrity Spine Lumbar Interbody Fusion SystemIntegrity Spine Lumbar Interbody Fusion System20154—
+4K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+4K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+4K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+4K150847Foundation Interbody DevicesCorelink, LLC201529—
+4K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+4K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+4K141798Sypher Spacer SystemBiogennix, LLC20151—
+4K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+4K142328nvcNvision Biomedical Technologies, LLC20144—
+4K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+4K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+4K141942Midline II TICentinel Spine, Inc.2014459—
+4K142016CAPRIK2m, Inc.201412—
+4K142026Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.2014190—
+4K141337Arena-CSpinefrontier, Inc.20141—
+4K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+4K141005Z-Link CervicalZavation, LLC20144—
+4K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+4K133815Intess Cervical Cage SystemKalitec Direct, LLC20144—
+4K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+4K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—