CD HORIZON ESSENCE™ Spinal System
GUDID 00643169428676
SCREW 45440007540 ESSENCE MAS 7.5X40
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00643169428676 |
| NIH Device Record Key | 6defabcc-b75d-4925-a2ca-996d63fb9362 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CD HORIZON ESSENCE™ Spinal System |
| Version Model Number | 45440007540 |
| 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
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169428676 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142591
FDA Product Code
| MNH | Orthosis, spondylolisthesis spinal fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00643169428676]
Moist Heat or Steam Sterilization
[00643169428676]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-02-26 |
| Device Publish Date | 2019-01-26 |
On-Brand Devices [CD HORIZON ESSENCE™ Spinal System]
| 00643169428898 | SET SCREW 4540020 ESSENCE BREAK-OFF |
| 00643169428812 | SCREW 45440004540 ESSENCE MAS 4.5X40 |
| 00643169428775 | SCREW 45440005540 ESSENCE MAS 5.5X40 |
| 00643169428751 | SCREW 45440005550 ESSENCE MAS 5.5X50 |
| 00643169428720 | SCREW 45440006540 ESSENCE MAS 6.5X40 |
| 00643169428676 | SCREW 45440007540 ESSENCE MAS 7.5X40 |
| 00643169428645 | SCREW 45440008560 ESSENCE MAS 8.5X60 |
| 00643169428560 | SCREW 45410005540 ESSENCE FAS 5.5X40 |
| 00643169428836 | SCREW 45440004520 ESSENCE MAS 4.5X20 |
Trademark Results [CD HORIZON ESSENCE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CD HORIZON ESSENCE 86265903 not registered Dead/Abandoned |
Warsaw Orthopedic, Inc. 2014-04-29 |
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