510(k) Report

Devices descending from K022793

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122317Tetris IISignus Medizintechnik GmbH20122—
+1K050997Expanse Vertebral Body Replacement DeviceFlexuspine, Inc.20050—
+1K050058Theken Reveal VBR SystemTheken Surgical,Llc2005727—
+1K033663Spinal Concepts Inc. CodaSpinal Concepts, Inc.20041—
+1K032064Theken Cpod/Lpod Vertebral Body Replacement SystemTheken Surgical,Llc20041,2801
+1K031757Peek Tetris Spinal ImplantSignus Medical, LLC20031,702—
+2K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+2K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+2K181899Roccia® PlifSilony Medical GmbH20180—
+2K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+2K123758Tasmin RSignus Medizintechnik GmbH20141—
+2K082712Theken Spine VU Epod and VU Lpod SystemTheken Spine, LLC2009118—
+2K080822VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC20087081
+2K072326Ostapek VBR SystemCo-Ligne AG20081—
+2K071031VU E*Pod Vertebral Body ReplacementTheken Spine, LLC2007119—
+2K070786X-Pod Adjustable Vertebral Body ReplacementTheken Spine, LLC20070—
+2K070381Theken VU Mesh VBR SystemTheken Spine, LLC200725—
+2K062151Box Peek VBR SystemInnovasis, Inc.2006175—
+2K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006789—
+2K061752Spinal Usa VBR SystemSpinal USA20060—
+2K052670Staxx XD SystemSpine Wave, Inc.20068—
+2K052533Kimba Spinal ImplantSignus Medizintechnik GmbH200541—
+2K050449Quantum Vertebral Body ReplacementQuantum Orthopedics, Inc.2005197—
+2K043479MC+ Partial VBRLdr Spine USA20051,214—
+2K043349Open Radiotransparent Intersomatic Implant (Roi)Ldr Spine USA2005134—
+2K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH20041,586—
+2K033109Ellys and Aurys Vertebral Body ReplacementsScient'X20041,218—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+3K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+3K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+3K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+3K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K173893TrabisColigne AG20180—
+3K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+3K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+3K172323Omnia Medical VBROmnia Medical, LLC20176—
+3K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+3K142488SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…Seaspine, Inc.2014116—
+3K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+3K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+3K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+3K132718Integrity Spine Core SystemIntegrity Spine20131—
+3K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+3K123969XiphosDifusion Technologies201314—
+3K123388K7C SpacerK7, LLC20130—
+3K121581Box Peek VBR System,Innovasis, Inc.20121—
+3K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216—
+3K112986Lateral Fusion DeviceIntegra Spine (Integra Lifesciences)2012126—
+3K111294Santorini Spinal SystemK2m, Inc.201218—
+3K112493Pass LP Spinal SystemMedicrea International20111—
+3K112359Prow FusionNlt Spine, Ltd.2011601—
+3K111965Vusion (R) OSOrtho Development20110—
+3K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+3K102315Staxx XDL SystemSpine Wave, Inc.20113—
+3K100305Eturn Spinal Implant Model Eturn XX-12; Eturn XX-16 Where XX=07, 09, 11, 13, or 15 and…Icotec20118—
+3K111469Staxxsd SystemSpine Wave, Inc.20110—
+3K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+3K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010864—
+3K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+3K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+3K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+3K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.201031—
+3K092904Pathway Ivb/VBRCustom Spine, Inc.2009296—
+3K090315Staxx XD SystemSpine Wave, Inc.20096—
+3K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009901—
+3K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+3K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009554—
+3K083857LDR Spine Roi-C ImplantLdr Spine USA2009902—
+3K080971Spinesmith Cimplicity Spinal SystemSpine Smith Partners L.P.2008406—
+3K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+3K080728LDR Spine Roi-C ImplantLdr Spine USA2008903—
+3K080860Creaspine Supstance Small Vertebral Body Replacement SystemCreaspine20080—
+3K080569LDR Spine Roi-T ImplantLdr Spine USA20080—
+3K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc.20087881
+3K080572LDR Spine Roi-a ImplantLdr Spine USA2008113—
+3K072537Creaspine Supstance Vertebral Body Replacement SystemCreaspine Sas20071—
+3K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+3K072132LDR Spine Roi-T SystemLdr Spine USA20071—
+3K071274Gso GS1 SpacerGold Standard Orthopedics, LLC20070—
+3K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated200760—
+3K063464Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20072—
+3K061082Mobis Spinal ImplantSignus Medizintechnik GmbH20060—
+3K052170Seaspine VBR SystemSeaspine, Inc.200513—
+3K051659Semial Spinal ImplantSignus Medizintechnik GmbH2005790—
+3K050348CO Vertebral Body ReplacementScient'X20052—
+3K043316Rabea Spinal ImplantSignus Medizintechnik GmbH20051,005—
+3K042930Spacevision Cage SystemSpine Vision, Inc.20041,440—
+4K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+4K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+4K243188Cylox® STSignus Medizintechnik GmbH20250—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—