K180498 is an FDA 510(k) clearance for the NuVasive Reline Fenestrated Screws, High V+ Bone Cement. This device is classified as a Bone Cement, Posterior Screw Augmentation (Class II - Special Controls, product code PML).
Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on November 28, 2018, 275 days after receiving the submission on February 26, 2018.
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 | K180498 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2018 |
| Decision Date | November 28, 2018 |
| Days to Decision | 275 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. |