The following data is part of a premarket notification filed by Medtronic Sofamor Danck Usa, Inc. with the FDA for Tsrh Spinal System.
| Device ID | K110070 |
| 510k Number | K110070 |
| Device Name: | TSRH SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDTRONIC SOFAMOR DANCK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Lila Joe |
| Correspondent | Lila Joe MEDTRONIC SOFAMOR DANCK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-10 |
| Decision Date | 2011-06-08 |
| Summary: | summary |