CD HORIZON ESSENCE™ Spinal System
GUDID 00763000794606
SCREW 45440005550 ESSENCE MAS 5.5X50
MEDTRONIC SOFAMOR DANEK, INC.
Spinal bone screw, non-bioabsorbable| Primary Device ID | 00763000794606 |
| NIH Device Record Key | 604bc054-38c0-4341-b04c-f2a5026b3e77 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CD HORIZON ESSENCE™ Spinal System |
| Version Model Number | 45440005550 |
| 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 | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000794606 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142591
FDA Product Code
| MNI | Orthosis, spinal pedicle fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000794606]
Moist Heat or Steam Sterilization
[00763000794606]
Moist Heat or Steam Sterilization
[00763000794606]
Moist Heat or Steam Sterilization
[00763000794606]
Moist Heat or Steam Sterilization
[00763000794606]
Moist Heat or Steam Sterilization
[00763000794606]
Moist Heat or Steam Sterilization
[00763000794606]
Moist Heat or Steam Sterilization
[00763000794606]
Moist Heat or Steam Sterilization
[00763000794606]
Moist Heat or Steam Sterilization
[00763000794606]
Moist Heat or Steam Sterilization
[00763000794606]
Moist Heat or Steam Sterilization
[00763000794606]
Moist Heat or Steam Sterilization
[00763000794606]
Moist Heat or Steam Sterilization
[00763000794606]
Moist Heat or Steam Sterilization
[00763000794606]
Moist Heat or Steam Sterilization
[00763000794606]
Moist Heat or Steam Sterilization
[00763000794606]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-18 |
| Device Publish Date | 2024-11-09 |
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 |
| 00763000802134 | SET SCREW 4540020 ESSENCE BREAK-OFF |
| 00763000794682 | SCREW 45440004520 ESSENCE MAS 4.5X20 |
| 00763000794668 | SCREW 45440004540 ESSENCE MAS 4.5X40 |
| 00763000794620 | SCREW 45440005540 ESSENCE MAS 5.5X40 |
| 00763000794606 | SCREW 45440005550 ESSENCE MAS 5.5X50 |
| 00763000794576 | SCREW 45440006540 ESSENCE MAS 6.5X40 |
| 00763000794521 | SCREW 45440007540 ESSENCE MAS 7.5X40 |
| 00763000794491 | SCREW 45440008560 ESSENCE MAS 8.5X60 |
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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