SAXXONY™ Posterior Cervical Thoracic System
GUDID 00889929021057
R2R Cross Connector, 40-52
NEXXT SPINE, LLC
Bone-screw internal spinal fixation system connector| Primary Device ID | 00889929021057 |
| NIH Device Record Key | fb0e7473-3542-4b0d-8bfb-283296ae429d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SAXXONY™ Posterior Cervical Thoracic System |
| Version Model Number | 12-RR-52 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889929021057 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182508
FDA Product Code
| KWP | Appliance, Fixation, Spinal Interlaminal |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889929021057]
Moist Heat or Steam Sterilization
[00889929021057]
Moist Heat or Steam Sterilization
[00889929021057]
Moist Heat or Steam Sterilization
[00889929021057]
Moist Heat or Steam Sterilization
[00889929021057]
Moist Heat or Steam Sterilization
[00889929021057]
Moist Heat or Steam Sterilization
[00889929021057]
Moist Heat or Steam Sterilization
[00889929021057]
Moist Heat or Steam Sterilization
[00889929021057]
Moist Heat or Steam Sterilization
[00889929021057]
Moist Heat or Steam Sterilization
[00889929021057]
Moist Heat or Steam Sterilization
[00889929021057]
Moist Heat or Steam Sterilization
[00889929021057]
Moist Heat or Steam Sterilization
[00889929021057]
Moist Heat or Steam Sterilization
[00889929021057]
Moist Heat or Steam Sterilization
[00889929021057]
Moist Heat or Steam Sterilization
[00889929021057]
Moist Heat or Steam Sterilization
[00889929021057]
Moist Heat or Steam Sterilization
[00889929021057]
Moist Heat or Steam Sterilization
[00889929021057]
Moist Heat or Steam Sterilization
[00889929021057]
Moist Heat or Steam Sterilization
[00889929021057]
Moist Heat or Steam Sterilization
[00889929021057]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-08-02 |
| Device Publish Date | 2018-12-04 |
On-Brand Devices [SAXXONY™ Posterior Cervical Thoracic System]
| 00889929032336 | Saxxony, Fixed Drill Guide, 16mm |
| 00889929032329 | Saxxony, Fixed Drill Guide, 14mm |
| 00889929032312 | Saxxony, Fixed Drill Guide, 12mm |
| 00889929032305 | Saxxony, Fixed Drill Guide, 10mm |
| 00889929032435 | T-Handle, AO, Torque Limiting, 35inlb |
| 00889929033210 | Saxxony Auxiliary Screw Caddy |
| 00889929033630 | Saxxony In-Situ Rod Bender, Right |
| 00889929033623 | Saxxony In-Situ Rod Bender, Left |
| 00889929033616 | Saxxony In-Situ Rod Bender, Straight |
| 00889929033944 | Posterior Smooth Screw, Ø4.0 x 44 |
| 00889929033937 | Posterior Smooth Screw, Ø4.0 x 42 |
| 00889929033920 | Posterior Smooth Screw, Ø4.0 x 40 |
| 00889929033913 | Posterior Smooth Screw, Ø3.5 x 44 |
| 00889929033906 | Posterior Smooth Screw, Ø3.5 x 42 |
| 00889929033890 | Posterior Smooth Screw, Ø3.5 x 40 |
| 00889929029046 | Crosslink Bender, Right |
| 00889929029039 | Crosslink Bender, Left |
| 00889929033968 | Rod Template, 240mm |
| 00889929035023 | Saxxony Rod Rocker Hook |
| 00889929041512 | Counter Torque |
| 00889929041505 | Axial Counter Torque |
| 00889929029763 | Screw Caddy, Ø3.5/4.0mm Smooth |
| 00889929029756 | Screw Caddy, Ø4.5 & 5.0mm |
| 00889929029749 | Screw Caddy, Ø4.0mm |
| 00889929029732 | Screw Caddy, Ø3.5mm Long |
| 00889929029725 | Screw Caddy, Ø3.5mm Short |
| 00889929029619 | Saxxony, Rod Implant & Instrument Case |
| 00889929029602 | Saxxony, Screw Implant & Instrument Case |
| 00889929028926 | Offset Connector Caddy |
| 00889929028919 | Set Screw Caddy |
| 00889929028902 | R2R Connector Caddy |
| 00889929028896 | Cross Connector Caddy |
| 00889929028889 | Rod Caddy |
| 00889929028872 | Screw Caddy |
| 00889929029022 | Rod Bender, 3.5mm |
| 00889929029008 | Connector Counter Torque |
| 00889929026472 | Adjustable Drill Guide |
| 00889929030417 | Posterior Screw, Ø5.0 x 45 |
| 00889929030400 | Posterior Screw, Ø5.0 x 40 |
| 00889929030394 | Posterior Screw, Ø5.0 x 35 |
| 00889929030387 | Posterior Screw, Ø5.0 x 25 |
| 00889929030370 | Posterior Screw, Ø4.5 x 20 |
| 00889929030332 | Posterior Screw, Ø4.5 x 25 |
| 00889929029572 | Posterior Smooth Screw, Ø4.0 x 38 |
| 00889929029565 | Posterior Smooth Screw, Ø4.0 x 36 |
| 00889929029558 | Posterior Smooth Screw, Ø4.0 x 34 |
| 00889929029541 | Posterior Smooth Screw, Ø4.0 x 32 |
| 00889929029534 | Posterior Smooth Screw, Ø4.0 x 30 |
| 00889929029527 | Posterior Smooth Screw, Ø4.0 x 28 |
| 00889929029510 | Posterior Smooth Screw, Ø4.0 x 26 |
Trademark Results [SAXXONY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SAXXONY 87560976 5723022 Live/Registered |
Nexxt Spine, LLC 2017-08-08 |
 SAXXONY 86169609 not registered Dead/Abandoned |
Nexxt Spine, LLC 2014-01-19 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.