510(k) Report

Devices descending from K022778

670 later devices reach Modification to TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+10K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+10K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+10K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+10K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+10K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+10K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+10K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+10K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+10K242042TriALTIS™ Spine SystemMedos International SARL20241—
+10K241846E3D™-C Interbody SystemEvolution Spine20246—
+10K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+10K240368E3D™-A Interbody SystemEvolution Spine20247—
+10K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+10K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+10K233300POWEReam 1/4 DriveStryker Instruments20231—
+10K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+10K233366SYMPHONY OCT SystemMedos International SARL20230—
+10K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+10K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+10K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+10K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+10K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+10K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+10K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+10K222789VADER® Pedicle System, G21 CementIcotec AG202352
+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—
+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—
+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—
+10K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+10K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+11K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+11K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+11K262094E3D™-C Interbody SystemEvolution Spine20260—
+11K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+11K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+11K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+11K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+11K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+11K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+11K260038E3D™-C Interbody SystemEvolution Spine20261—
+11K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+11K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+11K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+11K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+11K250637VCFix Spinal SystemAmber Implants20250—
+11K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+11K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+11K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+11K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+11K240526POWEReam Xia/SerratoStryker Instruments20240—
+11K232628VADER® Pedicle SystemIcotec AG20241—
+11K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+11K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+11K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+11K200896Solstice CCILife Spine, Inc.20200—
+11K182470Plateau Spacer SystemLife Spine20180—
+12K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+12K230989Rod Registration FrameNu Vasive, Incorporated20230—