The following data is part of a premarket notification filed by Medtronic with the FDA for Cd Horizon™ Spinal System.
| Device ID | K221244 | 
| 510k Number | K221244 | 
| Device Name: | CD Horizon™ Spinal System | 
| Classification | Thoracolumbosacral Pedicle Screw System | 
| Applicant | Medtronic 1800 Pyramid Place Memphis, TN 38132 | 
| Contact | Justin O'Connor | 
| Correspondent | Justin O'Connor Medtronic 1800 Pyramid Place Memphis, TN 38132 | 
| Product Code | NKB | 
| Subsequent Product Code | HBE | 
| Subsequent Product Code | KWP | 
| Subsequent Product Code | KWQ | 
| Subsequent Product Code | OLO | 
| CFR Regulation Number | 888.3070 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Special | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2022-05-02 | 
| Decision Date | 2022-05-25 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  CD HORIZON  75079759  2108361 Live/Registered | WARSAW ORTHOPEDIC, INC. 1996-03-28 |