The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Cd Horizon Eclipse.
| Device ID | K001066 |
| 510k Number | K001066 |
| Device Name: | CD HORIZON ECLIPSE |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Treharne |
| Correspondent | Richard Treharne MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-03 |
| Decision Date | 2000-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902183775 | K001066 | 000 |
| 00721902183546 | K001066 | 000 |
| 00721902183553 | K001066 | 000 |
| 00721902183560 | K001066 | 000 |
| 00721902183577 | K001066 | 000 |
| 00721902183584 | K001066 | 000 |
| 00721902183591 | K001066 | 000 |
| 00721902183607 | K001066 | 000 |
| 00721902183614 | K001066 | 000 |
| 00721902183621 | K001066 | 000 |
| 00721902183768 | K001066 | 000 |
| 00721902183539 | K001066 | 000 |