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
+1K070381Theken VU Mesh VBR SystemTheken Spine, LLC200725—
+1K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated200760—
+1K061082Mobis Spinal ImplantSignus Medizintechnik GmbH20060—
+1K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006789—
+1K052533Kimba Spinal ImplantSignus Medizintechnik GmbH200541—
+1K051659Semial Spinal ImplantSignus Medizintechnik GmbH2005790—
+1K050449Quantum Vertebral Body ReplacementQuantum Orthopedics, Inc.2005197—
+1K043349Open Radiotransparent Intersomatic Implant (Roi)Ldr Spine USA2005134—
+1K050058Theken Reveal VBR SystemTheken Surgical,Llc2005727—
+1K043316Rabea Spinal ImplantSignus Medizintechnik GmbH20051,005—
+1K042930Spacevision Cage SystemSpine Vision, Inc.20041,440—
+2K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+2K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+2K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+2K172323Omnia Medical VBROmnia Medical, LLC20176—
+2K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+2K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+2K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216—
+2K111294Santorini Spinal SystemK2m, Inc.201218—
+2K102315Staxx XDL SystemSpine Wave, Inc.20113—
+2K100305Eturn Spinal Implant Model Eturn XX-12; Eturn XX-16 Where XX=07, 09, 11, 13, or 15 and…Icotec20118—
+2K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.201031—
+2K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009554—
+2K082712Theken Spine VU Epod and VU Lpod SystemTheken Spine, LLC2009118—
+2K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc.200855—
+2K080822VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC20087081
+2K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+2K080569LDR Spine Roi-T ImplantLdr Spine USA20080—
+2K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc.20087881
+2K080572LDR Spine Roi-a ImplantLdr Spine USA2008113—
+2K072537Creaspine Supstance Vertebral Body Replacement SystemCreaspine Sas20071—
+2K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+2K072132LDR Spine Roi-T SystemLdr Spine USA20071—
+2K071274Gso GS1 SpacerGold Standard Orthopedics, LLC20070—
+2K071031VU E*Pod Vertebral Body ReplacementTheken Spine, LLC2007119—
+2K070786X-Pod Adjustable Vertebral Body ReplacementTheken Spine, LLC20070—
+2K063464Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20072—
+2K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.20071,406—
+2K062151Box Peek VBR SystemInnovasis, Inc.2006175—
+2K061752Spinal Usa VBR SystemSpinal USA20060—
+2K052170Seaspine VBR SystemSeaspine, Inc.200513—
+2K052096Nubic Spinal ImplantSignus Medical, LLC2005790—
+2K051454Aleutian Spacer SystemK2m, LLC2005666—
+2K051246Construx Mini Peek VBR SystemBlackstone Medical, Inc.2005834—
+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—
+3K191778Omnia Medical VBROmnia Medical, LLC20195—
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+3K181899Roccia® PlifSilony Medical GmbH20180—
+3K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+3K172480icotec Interbody Cage SystemIcotec AG20185—
+3K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+3K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+3K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+3K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+3K171704CAPRI Corpectomy Cage SystemK2m201710—
+3K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170—
+3K170055CAPRI Corpectomy Cage SystemK2m201711—
+3K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+3K151481Sahara Stabilization SystemK2m, Inc.20155—
+3K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+3K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+3K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+3K142488SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…Seaspine, Inc.2014116—
+3K142016CAPRIK2m, Inc.201412—
+3K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+3K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+3K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+3K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+3K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+3K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc.201414—
+3K133126K7 Lumbar SpacersK7, LLC20131—
+3K133207Staxx (R) SystemSpine Wave, Inc.20131—
+3K131636Polarus ConnectAcumed, LLC20130—
+3K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+3K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+3K122588Vusion CS PlusOrtho Development Corp.2013206—
+3K130434Octane Straight, Octane Straight - Lordotic, Octane Straight I/R, Octane Straight I/R -…Exactech, Inc.201311—
+3K123909Aesculap Cespace XPAesculap Implant System, Inc.20137—
+3K123969XiphosDifusion Technologies201314—
+3K123134Easyspine SystemLdr Spine USA, Inc.20131—
+3K121581Box Peek VBR System,Innovasis, Inc.20121—
+3K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+3K112986Lateral Fusion DeviceIntegra Spine (Integra Lifesciences)2012126—
+3K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+3K113478Plif CageEisertech, LLC2012269—
+3K112862Mecta-CMedacta International201114—
+3K112493Pass LP Spinal SystemMedicrea International20111—
+3K112359Prow FusionNlt Spine, Ltd.2011601—
+3K111965Vusion (R) OSOrtho Development20110—
+3K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+3K110915Cervical CageEisertech, LLC201123—
+3K110843Aleutian Spacer SystemK2m, Inc.2011589—
+3K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—
+3K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151