Struxxure®-L System
GUDID 00889929055953
Struxxure-L Plate System Case
NEXXT SPINE, LLC
Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable| Primary Device ID | 00889929055953 |
| NIH Device Record Key | 8014002e-6059-4f20-a2e5-ae6eb7a15aef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Struxxure®-L System |
| Version Model Number | C63-01-01L |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889929055953 [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 |
[00889929055953]
Moist Heat or Steam Sterilization
[00889929055953]
Moist Heat or Steam Sterilization
[00889929055953]
Moist Heat or Steam Sterilization
[00889929055953]
Moist Heat or Steam Sterilization
[00889929055953]
Moist Heat or Steam Sterilization
[00889929055953]
Moist Heat or Steam Sterilization
[00889929055953]
Moist Heat or Steam Sterilization
[00889929055953]
Moist Heat or Steam Sterilization
[00889929055953]
Moist Heat or Steam Sterilization
[00889929055953]
Moist Heat or Steam Sterilization
[00889929055953]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-30 |
| Device Publish Date | 2024-04-22 |
On-Brand Devices [Struxxure®-L System]
| 00889929042854 | Lateral Plate Set Screw |
| 00889929041215 | Lateral, 2 Hole Plate, Size 20 |
| 00889929041208 | Lateral, 2 Hole Plate, Size 18 |
| 00889929041192 | Lateral, 2 Hole Plate, Size 16 |
| 00889929041185 | Lateral, 2 Hole Plate, Size 14 |
| 00889929041178 | Lateral, 2 Hole Plate, Size 12 |
| 00889929041161 | Lateral, 2 Hole Plate, Size 10 |
| 00889929041154 | Lateral, 2 Hole Plate, Size 8 |
| 00889929053010 | Struxxure Lumbar Slap Hammer Adapter |
| 00889929055953 | Struxxure-L 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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