Class Class II
CD Horizon Spinal System (K223494)
Description
CD Horizon Spinal System by Medtronic, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223494
Clearance Date2023-01-23
Clearance TypeTraditional
Product CodeNKB
Regulation Number888.3070
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223494
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. CD Horizon Spinal System (K223494) cites 8 predicate devices and is itself cited by 4 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221646 | CD HORIZON ASTUTE SPINAL SYSTEM; CD HORIZON Growth Rod C... | Medtronic Sofamor Danek USA, Inc. | 2022 |
| K221244 | CD Horizon Spinal System | Medtronic | 2022 |
| K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Techno... | Medtronic Sofamor Danek USA | 2022 |
| K210637 | CD Horizon Spinal System | Medtronic | 2021 |
| K201407 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2020 |
| K162379 | CD HORIZON® Spinal System | Medtronic Sofamor Danek USA, Inc. | 2016 |
| K113174 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2011 |
| K042025 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2004 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241082 | INNOVERSE Navigation Instruments | Innosys Co., Ltd. | 2024 |
| K233951 | CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, ... | Medtronic Sofamor Danek USA, Inc. | 2024 |
| K223493 | PBC Separator with Selux AST System | Selux Diagnostics, Inc. | 2024 |
| K233508 | iFuse Bedrock Granite® Implant System | SI-BONE, Inc. | 2024 |
Trace the full predicate network for K223494
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.