CD Horizon® Ballast™ Spinal System
GUDID 00643169523852
TRAY 2950006 NAVIGATION INSTRUMENTS
MEDTRONIC SOFAMOR DANEK, INC.
Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable| 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.
| 00643169281165 - CD HORIZON® ASTUTE™ SPINAL SYSTEM | 2024-05-27 PEEK ROD 1608451070 6.0 X 6.9MM STR 70MM |
| 00763000242503 - MSB Reusable Instruments | 2024-05-27 GRAFT DELIVERY 6061007 GUN HANDLE |
| 00763000914103 - MSB Reusable Instruments | 2024-05-27 OSTEOTOME EX0823011 1/4 WIDE SHARP |
| 00763000914110 - MSB Reusable Instruments | 2024-05-27 OSTEOTOME EX0823012 1/2 WIDE SHARP |
| 00763000940454 - Medtronic Reusable Instruments | 2024-05-27 TRIAL X0420013 16DEG 16MM LARGE |
| 00763000940607 - Medtronic Reusable Instruments | 2024-05-27 TRIAL X0420028 20DEG 14MM LARGE |
| 00763000940614 - Medtronic Reusable Instruments | 2024-05-27 TRIAL X0420029 20DEG 16MM LARGE |
| 00763000940621 - Medtronic Reusable Instruments | 2024-05-27 TRIAL X0420030 20DEG 18MM LARGE |
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.