The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Modification To Cd Horizon Spinal System.
| Device ID | K031833 |
| 510k Number | K031833 |
| Device Name: | MODIFICATION TO CD HORIZON SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| 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 | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-13 |
| Decision Date | 2003-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902873201 | K031833 | 000 |
| 00721902873416 | K031833 | 000 |
| 00721902873423 | K031833 | 000 |
| 00721902873478 | K031833 | 000 |
| 00721902873485 | K031833 | 000 |
| 00721902873492 | K031833 | 000 |
| 00721902873508 | K031833 | 000 |
| 00721902873515 | K031833 | 000 |
| 00721902873522 | K031833 | 000 |
| 00721902873409 | K031833 | 000 |
| 00721902873393 | K031833 | 000 |
| 00721902873386 | K031833 | 000 |
| 00721902873232 | K031833 | 000 |
| 00721902873256 | K031833 | 000 |
| 00721902873270 | K031833 | 000 |
| 00721902873287 | K031833 | 000 |
| 00721902873317 | K031833 | 000 |
| 00721902873348 | K031833 | 000 |
| 00721902873355 | K031833 | 000 |
| 00721902873362 | K031833 | 000 |
| 00721902873539 | K031833 | 000 |
| 00721902873546 | K031833 | 000 |
| 00721902908668 | K031833 | 000 |
| 00721902908675 | K031833 | 000 |
| 00721902908682 | K031833 | 000 |
| 00721902908699 | K031833 | 000 |
| 00721902908705 | K031833 | 000 |
| 00721902908712 | K031833 | 000 |
| 00721902908729 | K031833 | 000 |
| 00721902908736 | K031833 | 000 |
| 00721902908620 | K031833 | 000 |
| 00721902908606 | K031833 | 000 |
| 00721902908583 | K031833 | 000 |
| 00721902873553 | K031833 | 000 |
| 00721902873560 | K031833 | 000 |
| 00721902873577 | K031833 | 000 |
| 00721902873584 | K031833 | 000 |
| 00721902873607 | K031833 | 000 |
| 00721902908545 | K031833 | 000 |
| 00721902908552 | K031833 | 000 |
| 00721902908569 | K031833 | 000 |
| 00721902947261 | K031833 | 000 |