The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Tsrh Spinal System.
| Device ID | K021170 |
| 510k Number | K021170 |
| Device Name: | TSRH SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-12 |
| Decision Date | 2002-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902733468 | K021170 | 000 |
| 00721902733451 | K021170 | 000 |
| 00721902733437 | K021170 | 000 |
| 00721902733420 | K021170 | 000 |
| 00721902733406 | K021170 | 000 |
| 00721902733390 | K021170 | 000 |