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 | K042167 |
| 510k Number | K042167 |
| Device Name: | MODIFICATION TO: CD HORIZON SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| 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 | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-11 |
| Decision Date | 2004-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885074183978 | K042167 | 000 |
| 00885074183862 | K042167 | 000 |
| 00885074183879 | K042167 | 000 |
| 00885074183893 | K042167 | 000 |
| 00885074183909 | K042167 | 000 |
| 00885074183916 | K042167 | 000 |
| 00885074183923 | K042167 | 000 |
| 00885074183930 | K042167 | 000 |
| 00885074183947 | K042167 | 000 |
| 00885074183954 | K042167 | 000 |
| 00885074183961 | K042167 | 000 |
| 00885074183855 | K042167 | 000 |