510(k) Report

Devices descending from K031757

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123758Tasmin RSignus Medizintechnik GmbH20141—
+1K122317Tetris IISignus Medizintechnik GmbH20122—
+1K070381Theken VU Mesh VBR SystemTheken Spine, LLC200725—
+1K062151Box Peek VBR SystemInnovasis, Inc.2006175—
+1K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006789—
+1K061752Spinal Usa VBR SystemSpinal USA20060—
+1K052670Staxx XD SystemSpine Wave, Inc.20068—
+1K052533Kimba Spinal ImplantSignus Medizintechnik GmbH200541—
+1K050449Quantum Vertebral Body ReplacementQuantum Orthopedics, Inc.2005197—
+1K043349Open Radiotransparent Intersomatic Implant (Roi)Ldr Spine USA2005134—
+1K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH20041,586—
+1K033663Spinal Concepts Inc. CodaSpinal Concepts, Inc.20041—
+1K033109Ellys and Aurys Vertebral Body ReplacementsScient'X20041,218—
+2K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+2K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+2K181899Roccia® PlifSilony Medical GmbH20180—
+2K172323Omnia Medical VBROmnia Medical, LLC20176—
+2K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+2K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+2K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+2K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+2K121581Box Peek VBR System,Innovasis, Inc.20121—
+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—
+2K111469Staxxsd SystemSpine Wave, Inc.20110—
+2K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.201031—
+2K090315Staxx XD SystemSpine Wave, Inc.20096—
+2K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009554—
+2K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+2K080860Creaspine Supstance Small Vertebral Body Replacement SystemCreaspine20080—
+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—
+2K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated200760—
+2K063464Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20072—
+2K061082Mobis Spinal ImplantSignus Medizintechnik GmbH20060—
+2K052170Seaspine VBR SystemSeaspine, Inc.200513—
+2K050997Expanse Vertebral Body Replacement DeviceFlexuspine, Inc.20050—
+2K051659Semial Spinal ImplantSignus Medizintechnik GmbH2005790—
+2K043479MC+ Partial VBRLdr Spine USA20051,214—
+2K050348CO Vertebral Body ReplacementScient'X20052—
+2K050058Theken Reveal VBR SystemTheken Surgical,Llc2005727—
+2K043316Rabea Spinal ImplantSignus Medizintechnik GmbH20051,005—
+2K042930Spacevision Cage SystemSpine Vision, Inc.20041,440—
+3K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+3K191778Omnia Medical VBROmnia Medical, LLC20195—
+3K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+3K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K172480icotec Interbody Cage SystemIcotec AG20185—
+3K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+3K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+3K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+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—
+3K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+3K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+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
+3K142016CAPRIK2m, Inc.201412—
+3K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+3K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+3K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc.201414—
+3K133126K7 Lumbar SpacersK7, LLC20131—
+3K133207Staxx (R) SystemSpine Wave, Inc.20131—
+3K132718Integrity Spine Core SystemIntegrity Spine20131—
+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—
+3K123909Aesculap Cespace XPAesculap Implant System, Inc.20137—
+3K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+3K123134Easyspine SystemLdr Spine USA, Inc.20131—
+3K123388K7C SpacerK7, LLC20130—
+3K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+3K113478Plif CageEisertech, LLC2012269—
+3K112862Mecta-CMedacta International201114—
+3K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+3K110915Cervical CageEisertech, LLC201123—
+3K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—
+3K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+3K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc.20111121
+3K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+3K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+3K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+3K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010864—
+3K101288Staxx XD SystemSpine Wave, Inc.201051
+3K100889Endoskeleton TCTitan Spine, LLC2010455—
+3K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—