CD Horizon® Ballast™ Spinal System
GUDID 00643169523852
TRAY 2950006 NAVIGATION INSTRUMENTS
MEDTRONIC SOFAMOR DANEK, INC.
Instrument tray| Primary Device ID | 00643169523852 |
| NIH Device Record Key | ceb597e9-91ad-4beb-a7f3-76411bf2e38d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CD Horizon® Ballast™ Spinal System |
| Version Model Number | 2950006 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169523852 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K153442
FDA Product Code
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
[00643169523852]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-08-09 |
| Device Publish Date | 2017-12-15 |
Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.
| 00643169593916 - CD HORIZON® Spinal System | 2024-09-17 XLINK 5442325 4.75 PROLOCK MLT 25-27MM |
| 00643169593992 - CD HORIZON® Spinal System | 2024-09-17 XLINK 5542326 5/6 PROLOCK MLT 26-28MM |
| 00763000085346 - ARTiC-L™ Spinal System | 2024-09-17 TRIAL 5251000 L 25 HT 10 DEG 0 FIXED |
| 00643169594036 - CD HORIZON® Spinal System | 2024-09-16 XLINK 5542335 5/6 PROLOCK MLT 35-41MM |
| 00643169652781 - CD HORIZON® SOLERA® Spinal System | 2024-09-16 ROD X0914081 DUAL BEND 5.5 CCM PLS S 350 |
| 00673978929323 - MSB TELAMON Spinal System | 2024-09-16 INSTRUMENT 907-547 TAN DISCDISTRACTOR 7 |
| 00681490480758 - MSB Reusable Instruments | 2024-09-16 INSTRUMENT 1766106 DISTRACTION FORCEPS |
| 00721902851063 - CENTERPIECE™ Plate Fixation System | 2024-09-16 CASE 176-853R OD PLATE CADDY |
Trademark Results [CD Horizon]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CD HORIZON 75079759 2108361 Live/Registered |
WARSAW ORTHOPEDIC, INC. 1996-03-28 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.