Struxxure®-A System
GUDID 00889929041277
ALIF, 4 Hole Plate, Size 18
NEXXT SPINE, LLC
Spinal fixation plate, non-bioabsorbable| Primary Device ID | 00889929041277 |
| NIH Device Record Key | dc44a245-b31f-45d1-9f4d-7dce2d1c0a6a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Struxxure®-A System |
| Version Model Number | 63-04-18 |
| Company DUNS | 003489810 |
| Company Name | NEXXT SPINE, LLC |
| 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 | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com |
Device Dimensions
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
| Width | 22 Millimeter |
| Length | 37.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889929041277 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K202192
FDA Product Code
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
[00889929041277]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-08 |
| Device Publish Date | 2020-12-31 |
On-Brand Devices [Struxxure®-A System]
| 00889929041284 | ALIF, 4 Hole Plate, Size 20 |
| 00889929041277 | ALIF, 4 Hole Plate, Size 18 |
| 00889929041260 | ALIF, 4 Hole Plate, Size 16 |
| 00889929041253 | ALIF, 4 Hole Plate, Size 14 |
| 00889929041246 | ALIF, 4 Hole Plate, Size 12 |
| 00889929041239 | ALIF, 4 Hole Plate, Size 10 |
| 00889929041222 | ALIF, 4 Hole Plate, Size 8 |
| 00889929055946 | Struxxure-A Plate System Case |
Trademark Results [Struxxure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STRUXXURE 86169608 4822921 Live/Registered |
Nexxt Spine, LLC 2014-01-19 |
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