Facet Fixx™ Facet Screw System
GUDID 00889929019740
TransLaminar Screw, Partial Thread, Ø6.0 x 40mm
NEXXT SPINE, LLC
Spinal bone screw, non-bioabsorbable| Primary Device ID | 00889929019740 |
| NIH Device Record Key | ca1494b9-9f2b-4597-9573-1ed53e9c817f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Facet Fixx™ Facet Screw System |
| Version Model Number | 14-09-6040 |
| 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 Dimensions
| Outer Diameter | 6 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 40 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889929019740 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K131417
FDA Product Code
| MRW | System, Facet Screw Spinal Device |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889929019740]
Moist Heat or Steam Sterilization
[00889929019740]
Moist Heat or Steam Sterilization
[00889929019740]
Moist Heat or Steam Sterilization
[00889929019740]
Moist Heat or Steam Sterilization
[00889929019740]
Moist Heat or Steam Sterilization
[00889929019740]
Moist Heat or Steam Sterilization
[00889929019740]
Moist Heat or Steam Sterilization
[00889929019740]
Moist Heat or Steam Sterilization
[00889929019740]
Moist Heat or Steam Sterilization
[00889929019740]
Moist Heat or Steam Sterilization
[00889929019740]
Moist Heat or Steam Sterilization
[00889929019740]
Moist Heat or Steam Sterilization
[00889929019740]
Moist Heat or Steam Sterilization
[00889929019740]
Moist Heat or Steam Sterilization
[00889929019740]
Moist Heat or Steam Sterilization
[00889929019740]
Moist Heat or Steam Sterilization
[00889929019740]
Moist Heat or Steam Sterilization
[00889929019740]
Moist Heat or Steam Sterilization
[00889929019740]
Moist Heat or Steam Sterilization
[00889929019740]
Moist Heat or Steam Sterilization
[00889929019740]
Moist Heat or Steam Sterilization
[00889929019740]
Moist Heat or Steam Sterilization
[00889929019740]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-08-02 |
| Device Publish Date | 2017-03-25 |
On-Brand Devices [Facet Fixx™ Facet Screw System]
| 00889929011614 | Facet Fixx Case |
| 00889929011607 | Facet Fixx Case |
| 00889929011591 | Facet Fixx Translaminar Caddy, 5.0mm |
| 00889929011584 | Facet Fixx Translaminar Caddy, 4.5mm |
| 00889929011577 | Facet Fixx Transfacet Caddy, 5.0mm |
| 00889929011560 | Facet Fixx Transfacet Caddy, 4.5mm |
| 00889929024966 | Facet Fixx, Screw, Full Thread, No Washer, Ø6.0 x 40mm |
| 00889929024959 | Facet Fixx, Screw, Full Thread, No Washer, Ø5.5 x 40mm |
| 00889929024942 | Facet Fixx, Screw, Full Thread, Ø6.0 x 40mm |
| 00889929024935 | Facet Fixx, Screw, Full Thread, Ø5.5 x 40mm |
| 00889929024928 | Facet Fixx, Screw, Partial Thread, Ø6.0 x 40mm |
| 00889929024911 | Facet Fixx, Screw, Partial Thread, Ø5.5 x 40mm |
| 00889929019740 | TransLaminar Screw, Partial Thread, Ø6.0 x 40mm |
| 00889929019733 | TransLaminar Screw, Partial Thread, Ø5.5 x 40mm |
| 00889929019726 | TransLaminar Screw, Partial Thread, Ø5.0 x 40mm |
| 00889929019719 | TransLaminar Screw, Partial Thread, Ø4.5 x 40mm |
| 00889929019702 | TransLaminar Screw, Partial Thread, Ø4.5 x 30mm |
| 00889929019696 | TransLaminar Screw, Partial Thread, Ø4.5 x 25mm |
| 00889929019689 | TransLaminar Screw, Partial Thread, Ø4.5 x 20mm |
| 00889929001400 | Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 60mm |
| 00889929001394 | Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 55mm |
| 00889929001387 | Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 50mm |
| 00889929001370 | Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 47.5mm |
| 00889929001363 | Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 45mm |
| 00889929001356 | Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 42.5mm |
| 00889929001349 | Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 40mm |
| 00889929001332 | Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 35mm |
| 00889929001325 | Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 32.5mm |
| 00889929001318 | Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 30mm |
| 00889929001301 | Facet Fixx, Screw, Full Thread, No Washer, Ø5.5 x 27.5mm |
| 00889929001295 | Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 25mm |
| 00889929001288 | Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 20mm |
| 00889929001271 | Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 60mm |
| 00889929001264 | Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 55mm |
| 00889929001257 | Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 50mm |
| 00889929001240 | Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 47.5mm |
| 00889929001233 | Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 45mm |
| 00889929001226 | Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 42.5mm |
| 00889929001219 | Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 40mm |
| 00889929001202 | Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 35mm |
| 00889929001196 | Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 32.5mm |
| 00889929001189 | Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 30mm |
| 00889929001172 | Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 27.5mm |
| 00889929001165 | Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 25mm |
| 00889929001158 | Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 20mm |
| 00889929001127 | Facet Fixx, Screw, Full Thread, Ø5.0 x 50mm |
| 00889929001110 | Facet Fixx, Screw, Full Thread, Ø5.0 x 47.5mm |
| 00889929001103 | Facet Fixx, Screw, Full Thread, Ø5.0 x 45mm |
| 00889929001097 | Facet Fixx, Screw, Full Thread, Ø5.0 x 42.5mm |
| 00889929001080 | Facet Fixx, Screw, Full Thread, Ø5.0 x 40mm |
Trademark Results [Facet Fixx]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FACET FIXX 86169603 4596493 Live/Registered |
Nexxt Spine, LLC 2014-01-19 |
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