K160986 is an FDA 510(k) clearance for the Xenco Medical Pedicle Screw System. This device is classified as a Thoracolumbosacral Pedicle Screw System (Class II - Special Controls, product code NKB).
Submitted by Xenco Medical, LLC (San Diego, US). The FDA issued a Cleared decision on May 4, 2016, 26 days after receiving the submission on April 8, 2016.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070. Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion..
| 510(k) Number | K160986 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 2016 |
| Decision Date | May 04, 2016 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | NKB - Thoracolumbosacral Pedicle Screw System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |
| Definition | Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion. |