510(k) Report

Devices descending from K062807

676 later devices reach TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K223294SpineJack® Expansion KitStryker Instruments20221—
+10K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+10K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+10K222698CUVIS-spineCurexo, Inc.20220—
+10K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+10K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+10K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+10K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+10K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+10K213918DeGen Navigated InstrumentationDegen Medical20220—
+10K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+10K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+10K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+10K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+10K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+10K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+10K182240PASS LP Spinal SystemMedicrea International SA20182—
+10K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+10K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+10K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+10K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+10K172194Connector SystemOrthofix, Inc.2017162
+10K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+11K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+11K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+11K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+11K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+11K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+11K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+11K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+11K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+11K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+11K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+11K250637VCFix Spinal SystemAmber Implants20250—
+11K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+11K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+11K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+11K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+11K241846E3D™-C Interbody SystemEvolution Spine20246—
+11K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+11K240526POWEReam Xia/SerratoStryker Instruments20240—
+11K232628VADER® Pedicle SystemIcotec AG20241—
+11K232432E3D™-A Interbody SystemEvolution Spine20248—
+11K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+11K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+11K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+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—
+11K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+11K190751Connector SystemOrthofix, Inc.20193—
+11K190376PASS LP Spinal SystemMedicrea International SA201915
+11K182470Plateau Spacer SystemLife Spine20180—
+12K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+12K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+12K262094E3D™-C Interbody SystemEvolution Spine20260—
+12K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+12K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+12K260038E3D™-C Interbody SystemEvolution Spine20261—
+12K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+12K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+12K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+12K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+12K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+12K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+12K240368E3D™-A Interbody SystemEvolution Spine20247—
+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—
+12K230989Rod Registration FrameNu Vasive, Incorporated20230—
+12K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+13K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+13K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+13K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+13K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—