CD HORIZON® SOLERA Spinal System
GUDID 00643169652804
ROD X0914083 DUAL BEND 5.5 CCM PLS X 490
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00643169652804 |
| NIH Device Record Key | 9ed67dc8-6335-4dd9-a031-fb5582b19432 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CD HORIZON® SOLERA Spinal System |
| Version Model Number | X0914083 |
| 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 | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169652804 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121680
FDA Product Code
| MNH | Orthosis, spondylolisthesis spinal fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
[00643169652804]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-16 |
| Device Publish Date | 2024-07-08 |
Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.
| 00763000873226 - DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM | 2025-06-24 PLATE G7731505 DIVERGENCE MINI 15.5MM |
| 00763000873233 - DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM | 2025-06-24 PLATE G7731506 DIVERGENCE MINI 16.5MM |
| 00763000873325 - DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM | 2025-06-24 IMPLANT G7736527 MP LORDO 7MMX15MMX12MM |
| 00763000885755 - Endoskeleton™ TT Interbody System with Titan nanoLOCK™ Surface Technology | 2025-06-24 NANO SPACER 4114-3509-N TT 4 DG XLG 9MM |
| 00763000889135 - ATLANTIS® Anterior Cervical Plate System | 2025-06-24 SCREW 3120317 4.0 X 17 SELF TAP VAR |
| 00763000889470 - ATLANTIS® Anterior Cervical Plate System | 2025-06-24 SCREW 3125513 4.5 X 13 SELF DRILL VAR |
| 00763000873608 - DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM | 2025-06-24 SCREW PK2 G7733513 MINIP S-D 3.5MM X13MM |
| 00199150000517 - Medtronic Reusable Instruments | 2025-06-23 INSERTER X468001500 CC 15DEG UP SHORT |
Trademark Results [CD HORIZON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CD HORIZON 75079759 2108361 Live/Registered |
WARSAW ORTHOPEDIC, INC. 1996-03-28 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.