510(k) Report

Devices descending from K202771

21 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+1K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+1K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+1K211323ASTRA Spine SystemSpinecraft, LLC202112—
+1K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+1K210306GII Spinal Fixation SystemColigne AG20210—
+2K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+2K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+2K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+2K223273ASTRA Spine SystemSpinecraft, LLC20228—
+2K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K252322SIros-X SystemGenesys Spine20250—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—