K203678 is an FDA 510(k) clearance for the CD HORIZON™ Spinal System. This device is classified as a Posterior Metal/polymer Spinal System, Fusion (Class II - Special Controls, product code NQP).
Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on January 15, 2021, 29 days after receiving the submission on December 17, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070. 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..
| 510(k) Number | K203678 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2020 |
| Decision Date | January 15, 2021 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | NQP — Posterior Metal/polymer Spinal System, Fusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |
| Definition | 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. |