510(k) Report

Devices descending from K031381

175 later devices reach Ucr Spinal System, Laminar Hooks, Pedicle Hooks, and Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+6K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K252322SIros-X SystemGenesys Spine20250—
+7K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+7K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+7K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+7K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+7K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+7K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+7K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+8K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+9K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+9K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+10K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+10K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+11K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+11K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+11K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+11K232432E3D™-A Interbody SystemEvolution Spine20248—
+11K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+11K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+11K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+11K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+11K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+12K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+12K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+12K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+12K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+12K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+12K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+12K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+12K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+12K241846E3D™-C Interbody SystemEvolution Spine20246—
+12K240368E3D™-A Interbody SystemEvolution Spine20247—
+12K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+12K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+12K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+12K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+12K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+12K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+13K262094E3D™-C Interbody SystemEvolution Spine20260—
+13K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+13K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+13K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+13K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+13K260038E3D™-C Interbody SystemEvolution Spine20261—
+13K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+13K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+13K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+13K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+13K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+13K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+13K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+13K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+14K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—