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 | K011067 |
| 510k Number | K011067 |
| 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 | 2001-04-09 |
| Decision Date | 2001-05-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902066399 | K011067 | 000 |
| 00721902066009 | K011067 | 000 |
| 00721902066016 | K011067 | 000 |
| 00721902066023 | K011067 | 000 |
| 00721902066030 | K011067 | 000 |
| 00721902066061 | K011067 | 000 |
| 00721902066078 | K011067 | 000 |
| 00721902066085 | K011067 | 000 |
| 00721902066092 | K011067 | 000 |
| 00721902066108 | K011067 | 000 |
| 00721902066115 | K011067 | 000 |
| 00721902066122 | K011067 | 000 |
| 00721902066139 | K011067 | 000 |
| 00721902066146 | K011067 | 000 |
| 00721902066160 | K011067 | 000 |
| 00721902066177 | K011067 | 000 |
| 00721902066375 | K011067 | 000 |
| 00721902066382 | K011067 | 000 |
| 00721902065996 | K011067 | 000 |