K201362 is an FDA 510(k) clearance for the CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement. This device is classified as a Bone Cement, Posterior Screw Augmentation (Class II - Special Controls, product code PML).
Submitted by Medtronic (Memphis, US). The FDA issued a Cleared decision on August 19, 2020, 89 days after receiving the submission on May 22, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027. The Device Is Intended To Augment The Fixation Of Screws In A Posterior Spinal System Construct..
| 510(k) Number | K201362 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2020 |
| Decision Date | August 19, 2020 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PML — Bone Cement, Posterior Screw Augmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3027 |
| Definition | The Device Is Intended To Augment The Fixation Of Screws In A Posterior Spinal System Construct. |