The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc with the FDA for Vertex(r) Reconstruction System.
| Device ID | K152338 |
| 510k Number | K152338 |
| Device Name: | VERTEX(r) Reconstruction System |
| Classification | Posterior Cervical Screw System |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Victoria Scheitlin |
| Correspondent | Victoria Scheitlin MEDTRONIC SOFAMOR DANEK USA, INC 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-19 |
| Decision Date | 2015-10-28 |
| Summary: | summary |