510(k) Report

Devices descending from K083389

633 later devices reach Coalition Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K252742Navigated InstrumentsTyber Medical, LLC20251—
+9K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+9K253331PressON Spinal Fixation SystemNexus Spine20250—
+9K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+9K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+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—
+9K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+9K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+9K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+9K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+9K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+10K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K252322SIros-X SystemGenesys Spine20250—
+10K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+10K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+10K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+10K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+10K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+10K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+11K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+11K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+12K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+12K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—