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 |
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| 00763000873332 - DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM | 2025-05-19 IMPLANT G7736746 MP LORDO 6MMX17MMX14MM |
| 00763000873349 - DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM | 2025-05-19 IMPLANT G7736526 MP LORDO 6MMX15MMX12MM |
| 00763000873561 - LOW PROFILE CROSSLINK® System | 2025-05-19 19X10 CROSSLINK 6.35 TI STER |
| 00763000873578 - LOW PROFILE CROSSLINK® System | 2025-05-19 22X10 CROSSLINK 6.35 TI STER |
| 00763000873585 - LOW PROFILE CROSSLINK® System | 2025-05-19 25X10 CROSSLINK 6.35 TI STER |
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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