Struxxure® Plate System

GUDID 00889929058244

Struxxure Lumbar Screwdriver Outer

NEXXT SPINE, LLC

General internal orthopaedic fixation system implantation kit
Primary Device ID00889929058244
NIH Device Record Keyc881437f-deb5-4bef-b7c4-fe90e4f2c9e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameStruxxure® Plate System
Version Model NumberI63-02-05
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 Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100889929058244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889929058244]

Moist Heat or Steam Sterilization


[00889929058244]

Moist Heat or Steam Sterilization


[00889929058244]

Moist Heat or Steam Sterilization


[00889929058244]

Moist Heat or Steam Sterilization


[00889929058244]

Moist Heat or Steam Sterilization


[00889929058244]

Moist Heat or Steam Sterilization


[00889929058244]

Moist Heat or Steam Sterilization


[00889929058244]

Moist Heat or Steam Sterilization


[00889929058244]

Moist Heat or Steam Sterilization


[00889929058244]

Moist Heat or Steam Sterilization


[00889929058244]

Moist Heat or Steam Sterilization


[00889929058244]

Moist Heat or Steam Sterilization


[00889929058244]

Moist Heat or Steam Sterilization


[00889929058244]

Moist Heat or Steam Sterilization


[00889929058244]

Moist Heat or Steam Sterilization


[00889929058244]

Moist Heat or Steam Sterilization


[00889929058244]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-10
Device Publish Date2024-10-02

On-Brand Devices [Struxxure® Plate System]

00889929043066Plate, Guided Drill
00889929043004Inserter, Hex Inner Shaft
00889929042991Lateral Plate Inserter
00889929042984Lateral Construct Inserter
00889929042977ALIF Plate Inserter
00889929042960ALIF Construct Inserter
00889929042823Lumbar Straight Driver, T20
00889929042816Struxxure, Guided Angle Awl
00889929042809Struxxure, Guided Straight Awl
00889929041413Plate Set Screw Driver
00889929041406Lateral Plate Lock Tool
00889929041024Ø6.0mm Lumbar Screw, 60mm
00889929041017Ø6.0mm Lumbar Screw, 55mm
00889929041000Ø6.0mm Lumbar Screw, 50mm
00889929040997Ø6.0mm Lumbar Screw, 45mm
00889929040980Ø6.0mm Lumbar Screw, 40mm
00889929040973Ø6.0mm Lumbar Screw, 35mm
00889929040966Ø6.0mm Lumbar Screw, 30mm
00889929040959Ø6.0mm Lumbar Screw, 25mm
00889929040942Ø6.0mm Lumbar Screw, 20mm
00889929040935Ø6.0mm Lumbar Screw, 15mm
00889929040928Ø5.5mm Lumbar Screw, 60mm
00889929040911Ø5.5mm Lumbar Screw, 55mm
00889929040904Ø5.5mm Lumbar Screw, 50mm
00889929040898Ø5.5mm Lumbar Screw, 45mm
00889929040881Ø5.5mm Lumbar Screw, 40mm
00889929040874Ø5.5mm Lumbar Screw, 35mm
00889929040867Ø5.5mm Lumbar Screw, 30mm
00889929040850Ø5.5mm Lumbar Screw, 25mm
00889929040843Ø5.5mm Lumbar Screw, 20mm
00889929040836Ø5.5mm Lumbar Screw, 15mm
00889929040645ALIF Screw Caddy
00889929040638Lateral Screw Caddy
00889929040614ALIF Plate Caddy
00889929040607Lateral Plate Caddy
00889929043059Struxxure System Case
00889929045787Struxxure, Guided Drill
00889929045770Struxxure, Guided Angle Awl
00889929045763Struxxure, Guided Straight Awl
00889929045855Lumbar Straight Driver Sleeve
00889929058251Struxxure Lumbar Screwdriver Inner
00889929058244Struxxure Lumbar Screwdriver Outer

Trademark Results [Struxxure]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STRUXXURE
STRUXXURE
86169608 4822921 Live/Registered
Nexxt Spine, LLC
2014-01-19

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