Struxxure® Anterior Cervical Plate System

GUDID 00889929009055

Variable Screw, Self-Drill, Ø4.35x10 mm

NEXXT SPINE, LLC

Spinal fixation plate, non-bioabsorbable
Primary Device ID00889929009055
NIH Device Record Key92bcedba-ab11-4b8a-8204-ba3cd57875a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameStruxxure® Anterior Cervical Plate System
Version Model Number31-6-4310
Company DUNS003489810
Company NameNEXXT SPINE, LLC
Device Count1
DM Exempttrue
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 Perscriptionfalse
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

Device Dimensions

Length10 Millimeter
Outer Diameter4.35 Millimeter
Length10 Millimeter
Outer Diameter4.35 Millimeter
Length10 Millimeter
Outer Diameter4.35 Millimeter
Length10 Millimeter
Outer Diameter4.35 Millimeter
Length10 Millimeter
Outer Diameter4.35 Millimeter
Length10 Millimeter
Outer Diameter4.35 Millimeter
Length10 Millimeter
Outer Diameter4.35 Millimeter
Length10 Millimeter
Outer Diameter4.35 Millimeter
Length10 Millimeter
Outer Diameter4.35 Millimeter
Length10 Millimeter
Outer Diameter4.35 Millimeter
Length10 Millimeter
Outer Diameter4.35 Millimeter
Length10 Millimeter
Outer Diameter4.35 Millimeter
Length10 Millimeter
Outer Diameter4.35 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100889929009055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889929009055]

Moist Heat or Steam Sterilization

[00889929009055]

Moist Heat or Steam Sterilization

[00889929009055]

Moist Heat or Steam Sterilization

[00889929009055]

Moist Heat or Steam Sterilization

[00889929009055]

Moist Heat or Steam Sterilization

[00889929009055]

Moist Heat or Steam Sterilization

[00889929009055]

Moist Heat or Steam Sterilization

[00889929009055]

Moist Heat or Steam Sterilization

[00889929009055]

Moist Heat or Steam Sterilization

[00889929009055]

Moist Heat or Steam Sterilization

[00889929009055]

Moist Heat or Steam Sterilization

[00889929009055]

Moist Heat or Steam Sterilization

[00889929009055]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-09-18
Device Publish Date2015-08-01

On-Brand Devices [Struxxure® Anterior Cervical Plate System]

00889929041703Struxxure, Corpectomy Plate and Screw Caddy
00889929050279Struxxure, Corpectomy Plate and Screw Caddy
00889929009826Fixed Screw, Self-Tap, Ø4.35x15 mm
00889929009819Fixed Screw, Self-Tap, Ø4.35x13 mm
00889929009802Variable Screw, Self-Tap, Ø4.35x15 mm
00889929009796Variable Screw, Self-Tap, Ø4.35x13 mm
00889929009789Fixed Screw, Self-Drill, Ø4.35x15 mm
00889929009772Fixed Screw, Self-Drill, Ø4.35x13 mm
00889929009765Fixed Screw, Self-Drill, Ø4.0x15 mm
00889929009758Fixed Screw, Self-Drill, Ø4.0x13 mm
00889929009741Variable Screw, Self-Drill, Ø4.35x15 mm
00889929009734Variable Screw, Self-Drill, Ø4.35x13 mm
00889929009512Fixed Screw, Self-Tap, Ø4.35x20 mm
00889929009505Fixed Screw, Self-Tap, Ø4.35x18 mm
00889929009499Fixed Screw, Self-Tap, Ø4.35x16 mm
00889929009482Fixed Screw, Self-Tap, Ø4.35x14 mm
00889929009475Fixed Screw, Self-Tap, Ø4.35x12 mm
00889929009468Fixed Screw, Self-Tap, Ø4.35x10 mm
00889929009451Fixed Screw, Self-Tap, Ø4.0x20 mm
00889929009444Fixed Screw, Self-Tap, Ø4.0x18 mm
00889929009437Fixed Screw, Self-Tap, Ø4.0x16 mm
00889929009420Fixed Screw, Self-Tap, Ø4.0x14 mm
00889929009413Fixed Screw, Self-Tap, Ø4.0x12 mm
00889929009406Fixed Screw, Self-Tap, Ø4.0x10 mm
00889929009390Variable Screw, Self-Tap, Ø4.35x20 mm
00889929009383Variable Screw, Self-Tap, Ø4.35x18 mm
00889929009376Variable Screw, Self-Tap, Ø4.35x16 mm
00889929009369Variable Screw, Self-Tap, Ø4.35x14 mm
00889929009352Variable Screw, Self-Tap, Ø4.35x12 mm
00889929009345Variable Screw, Self-Tap, Ø4.35x10 mm
00889929009338Variable Screw, Self-Tap, Ø4.0x20 mm
00889929009321Variable Screw, Self-Tap, Ø4.0x19 mm
00889929009314Variable Screw, Self-Tap, Ø4.0x18 mm
00889929009307Variable Screw, Self-Tap, Ø4.0x17 mm
00889929009291Variable Screw, Self-Tap, Ø4.0x16 mm
00889929009284Variable Screw, Self-Tap, Ø4.0x15 mm
00889929009277Variable Screw, Self-Tap, Ø4.0x14 mm
00889929009260Variable Screw, Self-Tap, Ø4.0x13 mm
00889929009253Variable Screw, Self-Tap, Ø4.0x12 mm
00889929009246Variable Screw, Self-Tap, Ø4.0x11 mm
00889929009239Variable Screw, Self-Tap, Ø4.0x10 mm
00889929009222Fixed Screw, Self-Drill, Ø4.35x20 mm
00889929009215Fixed Screw, Self-Drill, Ø4.35x18 mm
00889929009208Fixed Screw, Self-Drill, Ø4.35x16 mm
00889929009192Fixed Screw, Self-Drill, Ø4.35x14 mm
00889929009185Fixed Screw, Self-Drill, Ø4.35x12 mm
00889929009178Fixed Screw, Self-Drill, Ø4.35x10 mm
00889929009161Fixed Screw, Self-Drill, Ø4.0x20 mm
00889929009154Fixed Screw, Self-Drill, Ø4.0x18 mm
00889929009147Fixed Screw, Self-Drill, Ø4.0x16 mm

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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