The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Modification To Tsrh Spinal System.
| Device ID | K011029 |
| 510k Number | K011029 |
| Device Name: | MODIFICATION TO TSRH SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle 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 | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-05 |
| Decision Date | 2001-06-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00681490919692 | K011029 | 000 |
| 00721902733413 | K011029 | 000 |
| 00681490909679 | K011029 | 000 |
| 00681490910743 | K011029 | 000 |
| 00681490911085 | K011029 | 000 |
| 00681490911566 | K011029 | 000 |
| 00681490911795 | K011029 | 000 |
| 00681490911825 | K011029 | 000 |
| 00681490911849 | K011029 | 000 |
| 00681490911863 | K011029 | 000 |
| 00681490911887 | K011029 | 000 |
| 00721902311239 | K011029 | 000 |