The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Modification To: Vertex Reconstruction System.
| Device ID | K052734 |
| 510k Number | K052734 |
| Device Name: | MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Treharne |
| Correspondent | Richard Treharne MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-30 |
| Decision Date | 2005-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994554963 | K052734 | 000 |
| 00613994328458 | K052734 | 000 |
| 00613994328441 | K052734 | 000 |
| 00613994328434 | K052734 | 000 |
| 00613994328427 | K052734 | 000 |
| 00613994328410 | K052734 | 000 |
| 00613994328403 | K052734 | 000 |
| 00613994267931 | K052734 | 000 |
| 00885074531465 | K052734 | 000 |
| 00885074531458 | K052734 | 000 |
| 00885074531434 | K052734 | 000 |
| 00885074531427 | K052734 | 000 |
| 00613994328465 | K052734 | 000 |
| 00613994328472 | K052734 | 000 |
| 00613994554956 | K052734 | 000 |
| 00613994554949 | K052734 | 000 |
| 00613994554932 | K052734 | 000 |
| 00613994554925 | K052734 | 000 |
| 00613994554918 | K052734 | 000 |
| 00613994554901 | K052734 | 000 |
| 00613994554895 | K052734 | 000 |
| 00613994554888 | K052734 | 000 |
| 00613994328502 | K052734 | 000 |
| 00613994328496 | K052734 | 000 |
| 00613994328489 | K052734 | 000 |
| 00885074531410 | K052734 | 000 |