Struxxure® MCS Anterior Cervical System
GUDID 00889929055045
2-Hole Plate, Size 7
NEXXT SPINE, LLC
Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable| Primary Device ID | 00889929055045 |
| NIH Device Record Key | 0becc585-d781-467c-a1f1-0d018b8ec04c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Struxxure® MCS Anterior Cervical System |
| Version Model Number | 33-02-07 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889929055045 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K240690
FDA Product Code
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
[00889929055045]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-29 |
| Device Publish Date | 2024-04-20 |
On-Brand Devices [Struxxure® MCS Anterior Cervical System]
| 00889929055762 | 4-Hole Plate, Size 12 |
| 00889929055755 | 4-Hole Plate, Size 11 |
| 00889929055748 | 3-Hole Plate, Size 12 |
| 00889929055731 | 3-Hole Plate, Size 11 |
| 00889929055724 | 2-Hole Plate, Size 12 |
| 00889929055717 | 2-Hole Plate, Size 11 |
| 00889929055564 | Punch Awl |
| 00889929055557 | Plate Inserter |
| 00889929055540 | Construct Inserter Post |
| 00889929055533 | Construct Inserter |
| 00889929055304 | 4-Hole Plate Loading Block |
| 00889929055298 | 3-Hole Plate Loading Block |
| 00889929055281 | 2-Hole Plate Loading Block |
| 00889929055274 | 4-Hole Plate Caddy |
| 00889929055267 | 3-Hole Plate Caddy |
| 00889929055250 | 2-Hole Plate Caddy |
| 00889929055199 | 4-Hole Plate, Size 10 |
| 00889929055182 | 4-Hole Plate, Size 9 |
| 00889929055175 | 4-Hole Plate, Size 8 |
| 00889929055168 | 4-Hole Plate, Size 7 |
| 00889929055151 | 4-Hole Plate, Size 6 |
| 00889929055144 | 4-Hole Plate, Size 5 |
| 00889929055137 | 3-Hole Plate, Size 10 |
| 00889929055120 | 3-Hole Plate, Size 9 |
| 00889929055113 | 3-Hole Plate, Size 8 |
| 00889929055106 | 3-Hole Plate, Size 7 |
| 00889929055090 | 3-Hole Plate, Size 6 |
| 00889929055083 | 3-Hole Plate, Size 5 |
| 00889929055076 | 2-Hole Plate, Size 10 |
| 00889929055069 | 2-Hole Plate, Size 9 |
| 00889929055052 | 2-Hole Plate, Size 8 |
| 00889929055045 | 2-Hole Plate, Size 7 |
| 00889929055038 | 2-Hole Plate, Size 6 |
| 00889929055021 | 2-Hole Plate, Size 5 |
| 00889929056509 | Struxxure MCS General Case |
| 00889929055960 | Struxxure MCS Case |
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.