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 | K043321 |
| 510k Number | K043321 |
| 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 | 2004-12-02 |
| Decision Date | 2005-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885074255651 | K043321 | 000 |
| 00885074255446 | K043321 | 000 |
| 00885074255439 | K043321 | 000 |
| 00885074255422 | K043321 | 000 |
| 00885074255415 | K043321 | 000 |
| 00885074255408 | K043321 | 000 |
| 00885074255392 | K043321 | 000 |
| 00885074255385 | K043321 | 000 |
| 00885074255378 | K043321 | 000 |
| 00885074255255 | K043321 | 000 |
| 00885074255248 | K043321 | 000 |
| 00885074255231 | K043321 | 000 |
| 00885074255224 | K043321 | 000 |
| 00885074255217 | K043321 | 000 |
| 00885074255200 | K043321 | 000 |
| 00885074255194 | K043321 | 000 |
| 00885074255453 | K043321 | 000 |
| 00885074255477 | K043321 | 000 |
| 00885074255644 | K043321 | 000 |
| 00885074255620 | K043321 | 000 |
| 00885074255613 | K043321 | 000 |
| 00885074255606 | K043321 | 000 |
| 00885074255590 | K043321 | 000 |
| 00885074255583 | K043321 | 000 |
| 00885074255576 | K043321 | 000 |
| 00885074255569 | K043321 | 000 |
| 00885074255552 | K043321 | 000 |
| 00885074255545 | K043321 | 000 |
| 00885074255538 | K043321 | 000 |
| 00885074255521 | K043321 | 000 |
| 00885074255514 | K043321 | 000 |
| 00885074255507 | K043321 | 000 |
| 00885074255491 | K043321 | 000 |
| 00885074255187 | K043321 | 000 |