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 ID00889929019740
NIH Device Record Keyca1494b9-9f2b-4597-9573-1ed53e9c817f
Commercial Distribution StatusIn Commercial Distribution
Brand NameFacet Fixx™ Facet Screw System
Version Model Number14-09-6040
Company DUNS003489810
Company NameNEXXT SPINE, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com

Device Dimensions

Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100889929019740 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRWSystem, Facet Screw Spinal Device

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-08-02
Device Publish Date2017-03-25

On-Brand Devices [Facet Fixx™ Facet Screw System]

00889929011614Facet Fixx Case
00889929011607Facet Fixx Case
00889929011591Facet Fixx Translaminar Caddy, 5.0mm
00889929011584Facet Fixx Translaminar Caddy, 4.5mm
00889929011577Facet Fixx Transfacet Caddy, 5.0mm
00889929011560Facet Fixx Transfacet Caddy, 4.5mm
00889929024966Facet Fixx, Screw, Full Thread, No Washer, Ø6.0 x 40mm
00889929024959Facet Fixx, Screw, Full Thread, No Washer, Ø5.5 x 40mm
00889929024942Facet Fixx, Screw, Full Thread, Ø6.0 x 40mm
00889929024935Facet Fixx, Screw, Full Thread, Ø5.5 x 40mm
00889929024928Facet Fixx, Screw, Partial Thread, Ø6.0 x 40mm
00889929024911Facet Fixx, Screw, Partial Thread, Ø5.5 x 40mm
00889929019740TransLaminar Screw, Partial Thread, Ø6.0 x 40mm
00889929019733TransLaminar Screw, Partial Thread, Ø5.5 x 40mm
00889929019726TransLaminar Screw, Partial Thread, Ø5.0 x 40mm
00889929019719TransLaminar Screw, Partial Thread, Ø4.5 x 40mm
00889929019702TransLaminar Screw, Partial Thread, Ø4.5 x 30mm
00889929019696TransLaminar Screw, Partial Thread, Ø4.5 x 25mm
00889929019689TransLaminar Screw, Partial Thread, Ø4.5 x 20mm
00889929001400Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 60mm
00889929001394Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 55mm
00889929001387Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 50mm
00889929001370Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 47.5mm
00889929001363Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 45mm
00889929001356Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 42.5mm
00889929001349Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 40mm
00889929001332Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 35mm
00889929001325Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 32.5mm
00889929001318Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 30mm
00889929001301Facet Fixx, Screw, Full Thread, No Washer, Ø5.5 x 27.5mm
00889929001295Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 25mm
00889929001288Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 20mm
00889929001271Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 60mm
00889929001264Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 55mm
00889929001257Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 50mm
00889929001240Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 47.5mm
00889929001233Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 45mm
00889929001226Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 42.5mm
00889929001219Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 40mm
00889929001202Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 35mm
00889929001196Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 32.5mm
00889929001189Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 30mm
00889929001172Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 27.5mm
00889929001165Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 25mm
00889929001158Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 20mm
00889929001127Facet Fixx, Screw, Full Thread, Ø5.0 x 50mm
00889929001110Facet Fixx, Screw, Full Thread, Ø5.0 x 47.5mm
00889929001103Facet Fixx, Screw, Full Thread, Ø5.0 x 45mm
00889929001097Facet Fixx, Screw, Full Thread, Ø5.0 x 42.5mm
00889929001080Facet Fixx, Screw, Full Thread, Ø5.0 x 40mm

Trademark Results [Facet Fixx]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FACET FIXX
FACET FIXX
86169603 4596493 Live/Registered
Nexxt Spine, LLC
2014-01-19

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