CD HORIZON ESSENTIALS™ Spinal System
GUDID 00643169595118
TRAY 7377002 SDS TL FIXATION INS 2 OF 2
MEDTRONIC SOFAMOR DANEK, INC.
Instrument tray| Primary Device ID | 00643169595118 |
| NIH Device Record Key | 43b4ab07-71dd-4d54-8193-c1fcd5f8f0b6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CD HORIZON ESSENTIALS™ Spinal System |
| Version Model Number | 7377002 |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169595118 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152457
FDA Product Code
| NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
Moist Heat or Steam Sterilization
[00643169595118]
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 | 2015-12-17 |
On-Brand Devices [CD HORIZON ESSENTIALS™ Spinal System]
| 00643169603493 | SCREW KIT E7545MASKIT ESSENCE MAS 7.5X45 |
| 00643169603486 | SCREW KIT E7540MASKIT ESSENCE MAS 7.5X40 |
| 00643169603455 | SCREW KIT E6550MASKIT ESSENCE MAS 6.5X50 |
| 00643169603448 | SCREW KIT E6545MASKIT ESSENCE MAS 6.5X45 |
| 00643169603431 | SCREW KIT E6540MASKIT ESSENCE MAS 6.5X40 |
| 00643169603424 | SCREW KIT E6535MASKIT ESSENCE MAS 6.5X35 |
| 00643169603387 | SCREW KIT E5540MASKIT ESSENCE MAS 5.5X40 |
| 00643169595132 | TRAY 7377004 SDS TL INTERBODY INS |
| 00643169595125 | TRAY 7377003 SDS TL DISC PREP INS |
| 00643169595118 | TRAY 7377002 SDS TL FIXATION INS 2 OF 2 |
| 00643169595101 | TRAY 7377001 SDS TL FIXATION INS 1 OF 2 |
| 00643169429062 | SCRW 45340006540 ESSENCE STRLEMAS6.5X40 |
| 00643169428959 | SCRW 45340007545 ESSENCE STRLEMAS7.5X45 |
| 00643169428928 | SET SCRW 4530020 ESSENCE STRL BREAK-OFF |
| 20643169490707 | ROD 5570ROD2PER PRE-BENT 5.5X70 TI STER |
| 20643169490691 | ROD 5560ROD2PER PRE-BENT 5.5X60 TI STER |
| 20643169490684 | ROD 5550ROD2PER PRE-BENT 5.5X50 TI STER |
| 20643169490677 | ROD 5540ROD2PER PRE-BENT 5.5X40 TI STER |
| 20643169490660 | ROD 5535ROD2PER PRE-BENT 5.5X35 TI STER |
Trademark Results [CD HORIZON ESSENTIALS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CD HORIZON ESSENTIALS 86702183 5023922 Live/Registered |
Warsaw Orthopedic, Inc. 2015-07-23 |
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