The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Tsrh Spinal System.
| Device ID | K081080 |
| 510k Number | K081080 |
| Device Name: | TSRH SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Melisa Lansky |
| Correspondent | Melisa Lansky MEDTRONIC SOFAMOR DANEK 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 |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-16 |
| Decision Date | 2008-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994444615 | K081080 | 000 |
| 00613994444608 | K081080 | 000 |
| 00613994444592 | K081080 | 000 |
| 00613994444585 | K081080 | 000 |
| 00613994444578 | K081080 | 000 |
| 00613994444561 | K081080 | 000 |
| 00613994444554 | K081080 | 000 |
| 00613994444547 | K081080 | 000 |