The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Vertex Reconstruction System, Vertext Select Reconstruction System.
| Device ID | K123906 |
| 510k Number | K123906 |
| Device Name: | VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Claire Evans |
| Correspondent | Claire Evans MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-19 |
| Decision Date | 2013-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994932433 | K123906 | 000 |
| 00643169098305 | K123906 | 000 |
| 00643169096974 | K123906 | 000 |