The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Architex Space Maintenance System.
| Device ID | K110259 |
| 510k Number | K110259 |
| Device Name: | ARCHITEX SPACE MAINTENANCE SYSTEM |
| Classification | Plate, Bone |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Kelly Davidson |
| Correspondent | Kelly Davidson MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-28 |
| Decision Date | 2011-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994799801 | K110259 | 000 |
| 20613994799665 | K110259 | 000 |
| 20613994799658 | K110259 | 000 |
| 20613994792291 | K110259 | 000 |
| 20613994792284 | K110259 | 000 |
| 20613994792277 | K110259 | 000 |
| 20613994792260 | K110259 | 000 |
| 20613994792253 | K110259 | 000 |
| 20613994792246 | K110259 | 000 |
| 20613994792239 | K110259 | 000 |
| 20613994792222 | K110259 | 000 |
| 20613994799672 | K110259 | 000 |
| 20613994799689 | K110259 | 000 |
| 20613994799696 | K110259 | 000 |
| 20613994799795 | K110259 | 000 |
| 20613994799788 | K110259 | 000 |
| 20613994799771 | K110259 | 000 |
| 20613994799764 | K110259 | 000 |
| 20613994799757 | K110259 | 000 |
| 20613994799740 | K110259 | 000 |
| 20613994799733 | K110259 | 000 |
| 20613994799726 | K110259 | 000 |
| 20613994799719 | K110259 | 000 |
| 20613994799702 | K110259 | 000 |
| 20613994792215 | K110259 | 000 |