The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Cd Horizon Spire Z Spinal System.
| Device ID | K123246 |
| 510k Number | K123246 |
| Device Name: | CD HORIZON SPIRE Z SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Julie Bassett |
| Correspondent | Julie Bassett 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 |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-17 |
| Decision Date | 2012-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169167445 | K123246 | 000 |