CD HORIZON™ Spinal System
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™ Spinal System.
Pre-market Notification Details
| Device ID | K182119 |
| 510k Number | K182119 |
| Device Name: | CD HORIZON™ Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Ankit K. Shah |
| Correspondent | Ankit K. Shah 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 | 2018-08-06 |
| Decision Date | 2018-08-29 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000048266 | K182119 | 000 |
| 00763000048235 | K182119 | 000 |
| 00763000048204 | K182119 | 000 |
| 00763000048174 | K182119 | 000 |
| 00763000584344 | K182119 | 000 |
| 00763000584337 | K182119 | 000 |
| 00763000584320 | K182119 | 000 |
| 00763000584313 | K182119 | 000 |
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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