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 | K030285 |
| 510k Number | K030285 |
| Device Name: | MODIFICATION TO TSRH SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| 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 | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-28 |
| Decision Date | 2003-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994321633 | K030285 | 000 |
| 00721902704567 | K030285 | 000 |
| 00721902714337 | K030285 | 000 |
| 00721902727092 | K030285 | 000 |
| 00721902727108 | K030285 | 000 |
| 00721902727115 | K030285 | 000 |
| 00721902727122 | K030285 | 000 |
| 00721902727139 | K030285 | 000 |
| 00613994321596 | K030285 | 000 |
| 00613994321602 | K030285 | 000 |
| 00613994321619 | K030285 | 000 |
| 00613994321626 | K030285 | 000 |
| 00721902701726 | K030285 | 000 |