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 | K021061 |
| 510k Number | K021061 |
| Device Name: | MODIFICATION TO CD HORIZON SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| 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 | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-02 |
| Decision Date | 2002-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902444012 | K021061 | 000 |
| 00721902443459 | K021061 | 000 |
| 00721902443350 | K021061 | 000 |
| 00721902443343 | K021061 | 000 |
| 00721902443329 | K021061 | 000 |
| 00721902443305 | K021061 | 000 |
| 00721902443251 | K021061 | 000 |
| 00721902443237 | K021061 | 000 |
| 00721902443220 | K021061 | 000 |
| 00721902443046 | K021061 | 000 |
| 00721902443022 | K021061 | 000 |
| 00721902443015 | K021061 | 000 |
| 00721902443497 | K021061 | 000 |
| 00721902443527 | K021061 | 000 |
| 00721902443985 | K021061 | 000 |
| 00721902443923 | K021061 | 000 |
| 00721902443879 | K021061 | 000 |
| 00721902443824 | K021061 | 000 |
| 00721902443725 | K021061 | 000 |
| 00721902443718 | K021061 | 000 |
| 00721902443671 | K021061 | 000 |
| 00721902443619 | K021061 | 000 |
| 00721902443589 | K021061 | 000 |
| 00721902443572 | K021061 | 000 |
| 00721902443541 | K021061 | 000 |
| 00721902443008 | K021061 | 000 |