510(k) Report

Devices descending from K151726

139 later devices reach AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+9K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+9K240368E3D™-A Interbody SystemEvolution Spine20247—
+9K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+9K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+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—
+9K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+9K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+9K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+9K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+10K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+10K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+10K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+10K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+10K252322SIros-X SystemGenesys Spine20250—
+10K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+10K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+10K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+10K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+10K241846E3D™-C Interbody SystemEvolution Spine20246—
+10K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+10K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+10K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+10K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+10K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+11K262094E3D™-C Interbody SystemEvolution Spine20260—
+11K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+11K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+11K260038E3D™-C Interbody SystemEvolution Spine20261—
+11K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+11K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+11K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+11K223326Axiom PSR SystemRestor3D202301
+12K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—