510(k) Report

Devices descending from K133904

43 later devices reach CD Horizon Spinal System Growth Rod Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+1K180227Polaris Spinal Growth SystemZimmer Biomet Spine, Inc.20181—
+1K172979NuVasive® Growth Rod Conversion SetNu Vasive, Incorporated20170—
+1K161028K2M Growing Spine SystemK2m, Inc.20163—
+1K150200CD HORIZON Growth Rod Conversion SetMedtronic Sofamor Danek USA, Incorporated201524—
+1K142587Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc.201411
+1K142114Xia® Growth Rod Conversion SetStryker Corporation201413—
+1K141509Isola and Expedium Growing Spine SystemsMedos Sarl20146—
+1K140750Shilla Growth Guidance SystemMedtronic Sofamor Danek USA, Inc.201427—
+2K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+2K251961SDS Growing RodBAAT Medical Products B.V.20260—
+2K241816VerteGlide Spinal Growth Guidance SystemOrthoPediatrics Corp.20250—
+2K233105RESPONSE™ Rib and Pelvic SystemOrthoPediatrics Corp.20240—
+2K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+2K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+2K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+2K193224Daytona® Small Stature Growth Rod Conversion SetSeaSpine Orthopedics Corporation20202—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+3K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+3K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+3K223494CD Horizon Spinal SystemMedtronic202317—
+4K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K253331PressON Spinal Fixation SystemNexus Spine20250—
+4K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+4K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+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—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K252322SIros-X SystemGenesys Spine20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—