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 | K052187 |
| 510k Number | K052187 |
| 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 |
| Subsequent Product Code | NQP |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-11 |
| Decision Date | 2005-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994393029 | K052187 | 000 |
| 00885074457109 | K052187 | 000 |
| 00885074464664 | K052187 | 000 |
| 00885074464718 | K052187 | 000 |
| 00885074466415 | K052187 | 000 |
| 00885074466422 | K052187 | 000 |
| 00885074466439 | K052187 | 000 |
| 00885074466446 | K052187 | 000 |
| 00885074468174 | K052187 | 000 |
| 00885074468181 | K052187 | 000 |
| 00885074468204 | K052187 | 000 |
| 00885074468211 | K052187 | 000 |
| 00613994962317 | K052187 | 000 |
| 00613994962324 | K052187 | 000 |
| 00643169140325 | K052187 | 000 |
| 00643169140332 | K052187 | 000 |
| 00885074457093 | K052187 | 000 |