510(k) Report

Devices descending from K222028

28 later devices reach IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+1K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+1K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+1K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+1K240368E3D™-A Interbody SystemEvolution Spine20247—
+1K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+1K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+1K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+1K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+2K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+2K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+2K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+2K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+2K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+2K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+2K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+2K241846E3D™-C Interbody SystemEvolution Spine20246—
+2K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+3K262094E3D™-C Interbody SystemEvolution Spine20260—
+3K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K260038E3D™-C Interbody SystemEvolution Spine20261—
+3K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+3K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+3K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+3K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—