The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Modification To Tsrh Spinal System.
| Device ID | K050282 |
| 510k Number | K050282 |
| Device Name: | MODIFICATION TO TSRH SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Treharne |
| Correspondent | Richard Treharne MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| 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 | 2005-02-07 |
| Decision Date | 2005-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885074285801 | K050282 | 000 |
| 00885074285795 | K050282 | 000 |
| 00885074285788 | K050282 | 000 |