CD Horizon™ Fenestrated Screw Set
Thoracolumbosacral Pedicle Screw System
Medtronic Sofamor Danek USA, Inc.
The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Cd Horizon™ Fenestrated Screw Set.
Pre-market Notification Details
| Device ID | K193011 |
| 510k Number | K193011 |
| Device Name: | CD Horizon™ Fenestrated Screw Set |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Lee Grant |
| Correspondent | Lee Grant Medtronic 1800 Pyramid Place Memphis, TN 38132 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-29 |
| Decision Date | 2020-01-10 |
Trademark Results [CD Horizon]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CD HORIZON 75079759 2108361 Live/Registered |
WARSAW ORTHOPEDIC, INC. 1996-03-28 |
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