Struxxure® Plate System
GUDID 00889929058244
Struxxure Lumbar Screwdriver Outer
NEXXT SPINE, LLC
General internal orthopaedic fixation system implantation kit| Primary Device ID | 00889929058244 |
| NIH Device Record Key | c881437f-deb5-4bef-b7c4-fe90e4f2c9e9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Struxxure® Plate System |
| Version Model Number | I63-02-05 |
| 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 | 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889929058244 [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 |
[00889929058244]
Moist Heat or Steam Sterilization
[00889929058244]
Moist Heat or Steam Sterilization
[00889929058244]
Moist Heat or Steam Sterilization
[00889929058244]
Moist Heat or Steam Sterilization
[00889929058244]
Moist Heat or Steam Sterilization
[00889929058244]
Moist Heat or Steam Sterilization
[00889929058244]
Moist Heat or Steam Sterilization
[00889929058244]
Moist Heat or Steam Sterilization
[00889929058244]
Moist Heat or Steam Sterilization
[00889929058244]
Moist Heat or Steam Sterilization
[00889929058244]
Moist Heat or Steam Sterilization
[00889929058244]
Moist Heat or Steam Sterilization
[00889929058244]
Moist Heat or Steam Sterilization
[00889929058244]
Moist Heat or Steam Sterilization
[00889929058244]
Moist Heat or Steam Sterilization
[00889929058244]
Moist Heat or Steam Sterilization
[00889929058244]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-10 |
| Device Publish Date | 2024-10-02 |
On-Brand Devices [Struxxure® Plate System]
| 00889929043066 | Plate, Guided Drill |
| 00889929043004 | Inserter, Hex Inner Shaft |
| 00889929042991 | Lateral Plate Inserter |
| 00889929042984 | Lateral Construct Inserter |
| 00889929042977 | ALIF Plate Inserter |
| 00889929042960 | ALIF Construct Inserter |
| 00889929042823 | Lumbar Straight Driver, T20 |
| 00889929042816 | Struxxure, Guided Angle Awl |
| 00889929042809 | Struxxure, Guided Straight Awl |
| 00889929041413 | Plate Set Screw Driver |
| 00889929041406 | Lateral Plate Lock Tool |
| 00889929041024 | Ø6.0mm Lumbar Screw, 60mm |
| 00889929041017 | Ø6.0mm Lumbar Screw, 55mm |
| 00889929041000 | Ø6.0mm Lumbar Screw, 50mm |
| 00889929040997 | Ø6.0mm Lumbar Screw, 45mm |
| 00889929040980 | Ø6.0mm Lumbar Screw, 40mm |
| 00889929040973 | Ø6.0mm Lumbar Screw, 35mm |
| 00889929040966 | Ø6.0mm Lumbar Screw, 30mm |
| 00889929040959 | Ø6.0mm Lumbar Screw, 25mm |
| 00889929040942 | Ø6.0mm Lumbar Screw, 20mm |
| 00889929040935 | Ø6.0mm Lumbar Screw, 15mm |
| 00889929040928 | Ø5.5mm Lumbar Screw, 60mm |
| 00889929040911 | Ø5.5mm Lumbar Screw, 55mm |
| 00889929040904 | Ø5.5mm Lumbar Screw, 50mm |
| 00889929040898 | Ø5.5mm Lumbar Screw, 45mm |
| 00889929040881 | Ø5.5mm Lumbar Screw, 40mm |
| 00889929040874 | Ø5.5mm Lumbar Screw, 35mm |
| 00889929040867 | Ø5.5mm Lumbar Screw, 30mm |
| 00889929040850 | Ø5.5mm Lumbar Screw, 25mm |
| 00889929040843 | Ø5.5mm Lumbar Screw, 20mm |
| 00889929040836 | Ø5.5mm Lumbar Screw, 15mm |
| 00889929040645 | ALIF Screw Caddy |
| 00889929040638 | Lateral Screw Caddy |
| 00889929040614 | ALIF Plate Caddy |
| 00889929040607 | Lateral Plate Caddy |
| 00889929043059 | Struxxure System Case |
| 00889929045787 | Struxxure, Guided Drill |
| 00889929045770 | Struxxure, Guided Angle Awl |
| 00889929045763 | Struxxure, Guided Straight Awl |
| 00889929045855 | Lumbar Straight Driver Sleeve |
| 00889929058251 | Struxxure Lumbar Screwdriver Inner |
| 00889929058244 | Struxxure Lumbar Screwdriver Outer |
Trademark Results [Struxxure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STRUXXURE 86169608 4822921 Live/Registered |
Nexxt Spine, LLC 2014-01-19 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.