The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Cd Horizon Spinal System, Ipc Powerease System.
| Device ID | K143019 |
| 510k Number | K143019 |
| Device Name: | CD HORIZON Spinal System, IPC POWEREASE System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Medtronic Sofamor Danek USA, Inc. Medtronic Sofamor Danek USA, Inc. Memphis, TN 38132 |
| Contact | Lila Joe |
| Correspondent | Lila Joe Medtronic Sofamor Danek USA, Inc. Medtronic Sofamor Danek USA, Inc. Memphis, TN 38132 |
| Product Code | NKB |
| Subsequent Product Code | HWE |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-20 |
| Decision Date | 2015-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169468764 | K143019 | 000 |
| 00643169465794 | K143019 | 000 |
| 00643169465787 | K143019 | 000 |
| 00643169465770 | K143019 | 000 |
| 00643169465763 | K143019 | 000 |
| 00643169465756 | K143019 | 000 |
| 00643169465749 | K143019 | 000 |
| 00643169465732 | K143019 | 000 |
| 00643169465725 | K143019 | 000 |
| 00643169465718 | K143019 | 000 |
| 00643169465701 | K143019 | 000 |
| 00643169465695 | K143019 | 000 |
| 00643169465688 | K143019 | 000 |
| 00643169465671 | K143019 | 000 |
| 00643169465664 | K143019 | 000 |
| 00643169468689 | K143019 | 000 |
| 00643169465800 | K143019 | 000 |
| 00643169465817 | K143019 | 000 |
| 00643169468740 | K143019 | 000 |
| 00643169468733 | K143019 | 000 |
| 00643169468726 | K143019 | 000 |
| 00643169468696 | K143019 | 000 |
| 00643169468672 | K143019 | 000 |
| 00643169468665 | K143019 | 000 |
| 00643169468641 | K143019 | 000 |
| 00643169468634 | K143019 | 000 |
| 00643169465909 | K143019 | 000 |
| 00643169465886 | K143019 | 000 |
| 00643169465862 | K143019 | 000 |
| 00643169465855 | K143019 | 000 |
| 00643169465848 | K143019 | 000 |
| 00643169465831 | K143019 | 000 |
| 00643169465824 | K143019 | 000 |
| 00643169465893 | K143019 | 000 |