CD HORIZON® Spinal System
GUDID 00613994234735
SET SCREW 7220950 PERC PEEK
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00613994234735 |
| NIH Device Record Key | b3190abf-5652-431d-b046-fcc5399a2c93 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CD HORIZON® Spinal System |
| Version Model Number | 7220950 |
| 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 | 00613994234735 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K061915
FDA Product Code
| NQP | POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-06-11 |
| Device Publish Date | 2015-08-21 |
Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.
| 00199150000708 - Medtronic Reusable Instruments | 2025-06-30 TRIAL X06180845 8MM X 45MM DL MODULAR |
| 00199150000715 - Medtronic Reusable Instruments | 2025-06-30 TRIAL X06180850 8MM X 50MM DL MODULAR |
| 00199150000722 - Medtronic Reusable Instruments | 2025-06-30 TRIAL X06180855 8MM X 55MM DL MODULAR |
| 00199150000739 - Medtronic Reusable Instruments | 2025-06-30 TRIAL X06181045 10MM X 45MM DL MODULAR |
| 00199150000746 - Medtronic Reusable Instruments | 2025-06-30 TRIAL X06181050 10MM X 50MM DL MODULAR |
| 00199150000753 - Medtronic Reusable Instruments | 2025-06-30 TRIAL X06181055 10MM X 55MM DL MODULAR |
| 00199150000760 - Medtronic Reusable Instruments | 2025-06-30 TRIAL X06181245 12MM X 45MM DL MODULAR |
| 00199150000777 - Medtronic Reusable Instruments | 2025-06-30 TRIAL X06181250 12MM X 50MM DL MODULAR |
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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