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 |