510(k) Report

Devices descending from K031757

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+3K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+3K092904Pathway Ivb/VBRCustom Spine, Inc.2009296—
+3K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009901—
+3K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+3K083857LDR Spine Roi-C ImplantLdr Spine USA2009902—
+3K082712Theken Spine VU Epod and VU Lpod SystemTheken Spine, LLC2009118—
+3K081880Atlas Spine SpacerAtlas Spine, Inc.20080—
+3K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc.200855—
+3K080971Spinesmith Cimplicity Spinal SystemSpine Smith Partners L.P.2008406—
+3K080822VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC20087081
+3K081564Creaspine Supstance Vertebral Body Replacement System Line ExtensionCreaspine20080—
+3K080728LDR Spine Roi-C ImplantLdr Spine USA2008903—
+3K071726ZUMASeaspine, Inc.200712—
+3K071031VU E*Pod Vertebral Body ReplacementTheken Spine, LLC2007119—
+3K071497Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20070—
+3K070786X-Pod Adjustable Vertebral Body ReplacementTheken Spine, LLC20070—
+3K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.20071,406—
+3K053292Davantis/Antelys Vertebral Body ReplacementsScient'X USA, Inc.20060—
+3K052096Nubic Spinal ImplantSignus Medical, LLC2005790—
+3K051454Aleutian Spacer SystemK2m, LLC2005666—
+3K051246Construx Mini Peek VBR SystemBlackstone Medical, Inc.2005834—
+4K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+4K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K251016MectaLIF 3D MetalMedacta International S.A.20250—
+4K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+4K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+4K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+4K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+4K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+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—
+4K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+4K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+4K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+4K212831MectaLIF ExtensionMedacta International S.A.20211—
+4K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K202637F3D Corpectomy SystemCorelink, LLC20201—
+4K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+4K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+4K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+4K201585Monterey AL Interbody SystemStryker Corporation202044
+4K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+4K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+4K192897icotec Cervical CageIcotec AG20201—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+4K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K190544XIHPOS™ ZFUZE™ Interbody Fusion SystemDifusion Technologies20190—
+4K1803473d CageFims Co., Ltd.20190—
+4K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+4K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+4K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+4K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+4K183092Kuros TLIF CageKuros Biosciences B.V20190—
+4K182477Cervical SpacerAdditive Implants, LLC201915—
+4K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+4K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+4K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+4K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+4K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+4K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+4K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+4K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+4K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+4K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+4K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+4K172816TiGer Shark™ SystemChoicespine, LP201859—
+4K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+4K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+4K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+4K173148ACIFColigne AG20171—
+4K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+4K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+4K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+4K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+4K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+4K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+4K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+4K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+4K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+4K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine20171—
+4K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—