510(k) Report

Devices descending from K052144

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+8K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+8K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+8K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+8K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+8K182470Plateau Spacer SystemLife Spine20180—
+8K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+8K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+8K172194Connector SystemOrthofix, Inc.2017162
+8K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+9K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+9K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K250637VCFix Spinal SystemAmber Implants20250—
+9K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+9K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+9K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+9K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+9K241846E3D™-C Interbody SystemEvolution Spine20246—
+9K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+9K240368E3D™-A Interbody SystemEvolution Spine20247—
+9K232628VADER® Pedicle SystemIcotec AG20241—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+9K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+9K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+9K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+9K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+9K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+9K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+9K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+9K190751Connector SystemOrthofix, Inc.20193—
+9K182182YUKON OCT Spinal SystemK2m20185—
+9K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+10K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+10K262094E3D™-C Interbody SystemEvolution Spine20260—
+10K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+10K260038E3D™-C Interbody SystemEvolution Spine20261—
+10K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+10K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+10K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+10K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+10K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+10K193129Yukon OCT Spinal SystemK2m, Inc.202001