510(k) Report

Devices descending from K122850

240 later devices reach Talos-C Cervical Intervertebral Body Fusion Devices through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+10K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+10K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K252742Navigated InstrumentsTyber Medical, LLC20251—
+10K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+10K253331PressON Spinal Fixation SystemNexus Spine20250—
+10K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+10K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+10K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+10K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+10K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+10K240368E3D™-A Interbody SystemEvolution Spine20247—
+10K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+10K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+10K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+10K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+10K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+10K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+10K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+10K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+10K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+11K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+11K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+11K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+11K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+11K252322SIros-X SystemGenesys Spine20250—
+11K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+11K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+11K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+11K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+11K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+11K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+11K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+12K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+12K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+12K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+13K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—