The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Spinedesign Spine Surgery Planning (software Application).
| Device ID | K142648 |
| 510k Number | K142648 |
| Device Name: | SPINEDESIGN Spine Surgery Planning (Software Application) |
| Classification | System, Image Processing, Radiological |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Lila Joe |
| Correspondent | Lila Joe MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-17 |
| Decision Date | 2015-05-22 |
| Summary: | summary |