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 | K072429 |
| 510k Number | K072429 |
| Device Name: | MODIFICATION TO TSRH SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Lee Grant |
| Correspondent | Lee Grant MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-29 |
| Decision Date | 2007-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994569608 | K072429 | 000 |
| 00613994568786 | K072429 | 000 |
| 00613994568748 | K072429 | 000 |
| 00613994568717 | K072429 | 000 |
| 00613994568687 | K072429 | 000 |
| 00613994568656 | K072429 | 000 |
| 00613994568625 | K072429 | 000 |
| 00613994568540 | K072429 | 000 |
| 00613994568519 | K072429 | 000 |
| 00613994568489 | K072429 | 000 |
| 00613994568458 | K072429 | 000 |
| 00613994568410 | K072429 | 000 |
| 00613994568380 | K072429 | 000 |
| 00613994568359 | K072429 | 000 |
| 00613994568328 | K072429 | 000 |
| 00613994568298 | K072429 | 000 |
| 00613994338471 | K072429 | 000 |
| 00613994338464 | K072429 | 000 |
| 00613994568816 | K072429 | 000 |
| 00613994568908 | K072429 | 000 |
| 00613994569578 | K072429 | 000 |
| 00613994569547 | K072429 | 000 |
| 00613994569516 | K072429 | 000 |
| 00613994569486 | K072429 | 000 |
| 00613994569448 | K072429 | 000 |
| 00613994569417 | K072429 | 000 |
| 00613994569387 | K072429 | 000 |
| 00613994569295 | K072429 | 000 |
| 00613994569288 | K072429 | 000 |
| 00613994569271 | K072429 | 000 |
| 00613994569240 | K072429 | 000 |
| 00613994569219 | K072429 | 000 |
| 00613994569189 | K072429 | 000 |
| 00613994569028 | K072429 | 000 |
| 00613994568991 | K072429 | 000 |
| 00613994568960 | K072429 | 000 |
| 00613994568939 | K072429 | 000 |
| 00613994338457 | K072429 | 000 |