The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Cd Horizon Spinal System.
| Device ID | K211958 |
| 510k Number | K211958 |
| Device Name: | CD Horizon Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Kelly Mcdonnell |
| Correspondent | Kelly Mcdonnell Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-24 |
| Decision Date | 2021-07-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000465599 | K211958 | 000 |
| 00763000465582 | K211958 | 000 |