510(k) Report

Devices descending from K201605

130 later devices reach EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K223326Axiom PSR SystemRestor3D202301
+4K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+4K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+5K252322SIros-X SystemGenesys Spine20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+5K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+5K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—