510(k) Report

Devices descending from K031757

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+6K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+6K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+6K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+6K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+6K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+6K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+6K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+6K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+6K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+6K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+6K223143SAGICO Spinal SystemSagico VA USA, LLC20230—
+6K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+6K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+6K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+6K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+6K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+6K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+6K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K223418DeGen Impulse AM™ SystemDegen Medical20236—
+6K223776PEEK Spinal Infusion CageChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+6K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+6K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+6K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+6K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+6K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+6K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+6K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+6K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+6K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+6K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+6K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+6K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+6K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K221578Hexanium ACIFSpinevision, S.A.S.20224—
+6K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+6K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+6K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+6K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+6K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+6K221172FOCUS Interbody SystemOc Medical Devices20220—
+6K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+6K222561AlignAcuity Surgical Devices, LLC202214—
+6K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+6K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+6K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+6K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K220610SOLO-LAurora Spine, Inc.20220—
+6K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+6K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+6K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+6K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+6K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+6K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+6K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+6K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+6K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+6K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+6K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+6K211740DualXAmplify Surgical, Inc.20211—
+6K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+6K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+6K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+6K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+6K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+6K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+6K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+6K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+6K211306LabyrinthZavation Medical Products, LLC20213—
+6K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+6K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+6K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+6K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+6K200919Idys ALIF 3DTiClariance20210—
+6K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+6K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+6K210359Hexanium TLIFSpinevision, S.A.S.20211—
+6K202380Born PT-LIF Cage HASpineworxx AG20210—
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+6K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+6K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+6K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+6K201287Impulse Interbody Fusion SystemDegen Medical20208—