The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Artisan Space Maintenance System.
| Device ID | K120271 |
| 510k Number | K120271 |
| Device Name: | ARTISAN SPACE MAINTENANCE SYSTEM |
| Classification | Plate, Bone |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Lin Wu |
| Correspondent | Lin Wu 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 | 2012-01-30 |
| Decision Date | 2012-05-30 |
| Summary: | summary |