K200596 is an FDA 510(k) clearance for the G21 Cement, VADER® Pedicle System. This device is classified as a Bone Cement, Posterior Screw Augmentation (Class II - Special Controls, product code PML).
Submitted by Icotec AG (9450 Altstaetten (Sg), CH). The FDA issued a Cleared decision on October 13, 2020, 221 days after receiving the submission on March 6, 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 | K200596 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2020 |
| Decision Date | October 13, 2020 |
| Days to Decision | 221 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. |