The following data is part of a premarket notification filed by Medtronic Soafamor Danek with the FDA for Vertex Reconstruction System, Vertex Select Reconstruction System.
| Device ID | K091365 |
| 510k Number | K091365 |
| Device Name: | VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | MEDTRONIC SOAFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Melisa Lansky |
| Correspondent | Melisa Lansky MEDTRONIC SOAFAMOR DANEK 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 | 2009-05-08 |
| Decision Date | 2009-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994763716 | K091365 | 000 |
| 00613994387011 | K091365 | 000 |
| 00643169104648 | K091365 | 000 |