The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc with the FDA for Vertex Reconstruction System.
| Device ID | K143471 |
| 510k Number | K143471 |
| Device Name: | VERTEX Reconstruction System |
| Classification | Posterior Cervical Screw System |
| Applicant | Medtronic Sofamor Danek USA, Inc 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Lee Grant |
| Correspondent | Lee Grant 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 | 2014-12-05 |
| Decision Date | 2015-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169414600 | K143471 | 000 |