510(k) Report

Devices descending from K201614

47 later devices reach TxTiHA IBF System, AxTiHA Stand-Alone ALIF System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+1K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+1K232432E3D™-A Interbody SystemEvolution Spine20248—
+1K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+1K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+1K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+2K260038E3D™-C Interbody SystemEvolution Spine20261—
+2K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+2K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+2K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+2K241846E3D™-C Interbody SystemEvolution Spine20246—
+2K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+2K240368E3D™-A Interbody SystemEvolution Spine20247—
+2K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+2K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+2K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+2K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+3K262094E3D™-C Interbody SystemEvolution Spine20260—
+3K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+3K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+3K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+3K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+3K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+3K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+3K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+3K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+3K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+4K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+4K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+4K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+4K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—