Medtronic Sofamor Danek USA, Inc. · Class II · Cleared Feb 6, 2015
| K-number | K143471 |
| Device name | VERTEX Reconstruction System |
| Applicant | Medtronic Sofamor Danek USA, Inc. |
| Product code | NKG |
| Device class | Class II |
| Decision date | Feb 6, 2015 |
| Decision | Substantially Equivalent |
| Regulation | 888.3075 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov