CD Horizon Astute Spinal System
FDA 510(k) K191066 · Medtronic Sofamor Danek USA, Inc.
510(k) numberK191066
Submission
- Device name
- CD Horizon Astute Spinal System
- Applicant
- Medtronic Sofamor Danek USA, Inc.
Memphis, TN, US - Received
- April 22, 2019
- Decision date
- October 3, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQP – Posterior Metal/Polymer Spinal System, Fusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
This device is a posterior spinal system that contains polymer and metal components. This spinal system is to be used with bone graft and is an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
Other 510(k)s with product code NQP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203678 | CD HORIZON Spinal SystemNQP · Special | Medtronic Sofamor Danek USA, Inc. | 01/15/2021SE |
| K182928 | CD Horizon Spinal SystemNQP · Traditional | Medtronic Sofamor Danek USA, Inc. | 01/11/2019SE |
| K133164 | Dynesys Top-Loading Spinal SystemNQP · Traditional | Zimmer Spine, Inc. | 01/16/2014SE |
| K101704 | Zimmer Dto Pin Press InstrumentNQP · Special | Zimmer Spine, Inc. | 08/18/2010SE |
| K101083 | DSS Stabilization SystemNQP · Special | Paradigm Spine, LLC | 07/02/2010SESU |
| K092234 | Dynesys Top-Loading Spinal SystemNQP · Traditional | Zimmer Spine, Inc. | 10/01/2009SE |
| K091944 | Modification to: DSS Stabilization SystemNQP · Special | Paradigm Spine, LLC | 08/03/2009SE |
| K073439 | Transition Stabilization SystemNQP · Traditional | Globus Medical, Inc. | 02/20/2009SESU |
| K080241 | DDS Stabilization SystemNQP · Traditional | Paradigm Spine, LLC | 11/28/2008SESU |
| K080963 | DSS Stabilization SystemNQP · Special | Paradigm Spine | 05/02/2008SE |
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| K253656 | OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation SystemGEI · Traditional | 06/05/2026SE |
| K260216 | CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal SystemNKB · Traditional | 04/21/2026SE |
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| K253941 | CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly)NKB · Special | 01/07/2026SE |
| K253335 | CD Horizon Spinal SystemNKB · Special | 10/24/2025SE |
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| K251444 | Endoskeleton Interbody SystemsMAX · Traditional | 09/04/2025SE |
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Questions and answers
When was CD Horizon Astute Spinal System cleared by the FDA?
CD Horizon Astute Spinal System (K191066) received a 510(k) decision of Substantially Equivalent on October 3, 2019, 164 days after the submission was received.
What is the product code of K191066?
The FDA product code is NQP – Posterior Metal/Polymer Spinal System, Fusion, a Class II (moderate risk) device regulated under 21 CFR 888.3070.