The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Tsrh Spinal System.
| Device ID | K010720 |
| 510k Number | K010720 |
| Device Name: | TSRH SPINAL SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-12 |
| Decision Date | 2001-04-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994760111 | K010720 | 000 |
| 00681490909747 | K010720 | 000 |
| 00681490909723 | K010720 | 000 |
| 00681490909662 | K010720 | 000 |
| 00681490523479 | K010720 | 000 |
| 00681490523462 | K010720 | 000 |
| 00681490523455 | K010720 | 000 |
| 00681490523448 | K010720 | 000 |
| 00681490523431 | K010720 | 000 |
| 00681490523424 | K010720 | 000 |
| 00681490523417 | K010720 | 000 |
| 00681490523400 | K010720 | 000 |
| 00681490523394 | K010720 | 000 |
| 00681490523387 | K010720 | 000 |
| 00721902030024 | K010720 | 000 |
| 00681490909754 | K010720 | 000 |
| 00681490909761 | K010720 | 000 |
| 00681490909778 | K010720 | 000 |
| 00613994760104 | K010720 | 000 |
| 00613994760098 | K010720 | 000 |
| 00613994760081 | K010720 | 000 |
| 00613994760074 | K010720 | 000 |
| 00613994760067 | K010720 | 000 |
| 00613994760050 | K010720 | 000 |
| 00681490919715 | K010720 | 000 |
| 00681490909877 | K010720 | 000 |
| 00681490909860 | K010720 | 000 |
| 00681490909853 | K010720 | 000 |
| 00681490909839 | K010720 | 000 |
| 00681490909815 | K010720 | 000 |
| 00681490909808 | K010720 | 000 |
| 00681490909785 | K010720 | 000 |
| 00721902030017 | K010720 | 000 |