K160879 is an FDA 510(k) clearance for the CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems. This device is classified as a Bone Cement, Posterior Screw Augmentation (Class II - Special Controls, product code PML).
Submitted by Medos International S?rl (Lelocle, CH). The FDA issued a Cleared decision on December 20, 2016, 265 days after receiving the submission on March 30, 2016.
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 | K160879 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2016 |
| Decision Date | December 20, 2016 |
| Days to Decision | 265 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. |