The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Tsrh Spinal System.
| Device ID | K032578 |
| 510k Number | K032578 |
| Device Name: | TSRH SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Treharne |
| Correspondent | Richard Treharne MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-21 |
| Decision Date | 2003-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902729782 | K032578 | 000 |
| 00721902729331 | K032578 | 000 |
| 00721902729355 | K032578 | 000 |
| 00721902729386 | K032578 | 000 |
| 00721902729423 | K032578 | 000 |
| 00721902729454 | K032578 | 000 |
| 00721902729478 | K032578 | 000 |
| 00721902729522 | K032578 | 000 |
| 00721902729553 | K032578 | 000 |
| 00721902729591 | K032578 | 000 |
| 00721902729638 | K032578 | 000 |
| 00721902729669 | K032578 | 000 |
| 00721902729690 | K032578 | 000 |
| 00721902729713 | K032578 | 000 |
| 00885074210933 | K032578 | 000 |