Struxxure™ Anterior Cervical Plate and Screws
GUDID 00889929022832
Variable Self-Tapping Screw Caddy, Odd Length mm
NEXXT SPINE, LLC
Sterilization/disinfection container, reusable| Primary Device ID | 00889929022832 |
| NIH Device Record Key | 8fdfdd7d-2442-4886-add6-a0923c1e797b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Struxxure™ Anterior Cervical Plate and Screws |
| Version Model Number | C31-02-18 |
| 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 | 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 | false |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889929022832 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133475
FDA Product Code
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
[00889929022832]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2021-07-08 |
| Device Publish Date | 2017-10-03 |
On-Brand Devices [Struxxure™ Anterior Cervical Plate and Screws]
| 00889929033067 | Lock Tool |
| 00889929019436 | Drill Guide, Double Barrel, Fixed, 0°, Long |
| 00889929019429 | Drill Guide, Double Barrel, Fixed, 15°, Long |
| 00889929035245 | Drill Guide, Double Barrel, Fixed, 0°, Sideways, Assembly |
| 00889929035238 | Drill Guide, Double Barrel, Fixed, 15°, Sideways, Assembly |
| 00889929030127 | Struxxure, THR Screw Caddy, Fixed Self Tapping |
| 00889929030110 | Struxxure, THR Screw Caddy, Variable Self Tapping |
| 00889929028421 | Struxxure, THR Screw Caddy, Fixed Self Drilling |
| 00889929028414 | Struxxure, THR Screw Caddy, Variable Self Drilling |
| 00889929022863 | Fixed + Var Screw Caddy, Self-Tapping |
| 00889929022856 | Fixed + Var Screw Caddy, Self-Drilling |
| 00889929022849 | Fixed Self-Tapping Screw Caddy, Odd Length mm |
| 00889929022832 | Variable Self-Tapping Screw Caddy, Odd Length mm |
| 00889929019665 | Variable Self-Drilling Screw Caddy, Odd Length mm |
| 00889929019658 | Fixed Self-Drilling Screw Caddy, Odd Length mm |
| 00889929019641 | Struxxure Fixed Screw Caddy |
| 00889929019634 | Struxxure Variable Screw Caddy |
| 00889929019627 | Struxxure Self-Tapping Screw Caddy, Fixed, Even |
| 00889929019610 | Struxxure Self-Tapping Screw Caddy, Variable, Even |
| 00889929019603 | Struxxure Self-Drilling Screw Caddy, Fixed, Even |
| 00889929019597 | Struxxure Self-Drilling Screw Caddy, Variable, Even |
| 00889929019580 | Struxxure Fixed Screw Caddy |
| 00889929019573 | Struxxure Variable Screw Caddy |
| 00889929019566 | Struxxure Case |
| 00889929019559 | Struxxure Plate Caddy, 5 Level |
| 00889929019542 | Struxxure Plate Caddy, 4 Level |
| 00889929019535 | Struxxure Plate Caddy, 3 Level |
| 00889929019528 | Struxxure Plate Caddy, 2 Level |
| 00889929019511 | Struxxure Plate Caddy, 1 Level |
| 00889929047026 | THR Fixed Screw, Self Drilling, Ø4.0x20mm |
| 00889929047019 | THR Variable Screw, Self Drilling, Ø4.0x20mm |
| 00889929049075 | AC Plate, 3 Level, 76mm |
| 00889929049068 | AC Plate, 3 Level, 74mm |
| 00889929049051 | AC Plate, 3 Level, 70mm |
| 00889929049044 | AC Plate, 3 Level, 68mm |
| 00889929049037 | AC Plate, 3 Level, 64mm |
| 00889929049020 | AC Plate, 3 Level, 62mm |
| 00889929049013 | AC Plate, 3 Level, 58mm |
| 00889929049006 | AC Plate, 3 Level, 56mm |
| 00889929048993 | AC Plate, 3 Level, 52mm |
| 00889929048986 | AC Plate, 3 Level, 50mm |
| 00889929051337 | Fixed, Self-Tap, Screw Caddy |
| 00889929051320 | Variable, Self-Tap, Screw Caddy |
| 00889929051313 | Fixed, Self-Drill, Screw Caddy |
| 00889929051306 | Variable, Self-Drill, Screw Caddy |
| 00889929051818 | Corpectomy-Struxxure Implant & Instrument Case |
| 00889929030936 | THR Fixed Screw, Self Tapping, Ø4.35x26mm |
| 00889929030929 | THR Fixed Screw, Self Tapping, Ø4.0x26mm |
| 00889929030912 | THR Variable Screw, Self Tapping, Ø4.35x26mm |
| 00889929030905 | THR Variable Screw, Self Tapping, Ø4.0x26mm |
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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