Struxxure™ Anterior Cervical Plate and Screws

GUDID 00889929025307

Fixed Screw, Self-Drill, Ø4.35x19 mm

NEXXT SPINE, LLC

Spinal fixation plate, non-bioabsorbable
Primary Device ID00889929025307
NIH Device Record Keya4a36471-54f5-4f57-95c3-4a5787fe83dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameStruxxure™ Anterior Cervical Plate and Screws
Version Model Number31-7-4319
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

Outer Diameter4.35 Millimeter
Length19 Millimeter
Outer Diameter4.35 Millimeter
Length19 Millimeter
Outer Diameter4.35 Millimeter
Length19 Millimeter
Outer Diameter4.35 Millimeter
Length19 Millimeter
Outer Diameter4.35 Millimeter
Length19 Millimeter
Outer Diameter4.35 Millimeter
Length19 Millimeter
Outer Diameter4.35 Millimeter
Length19 Millimeter
Outer Diameter4.35 Millimeter
Length19 Millimeter
Outer Diameter4.35 Millimeter
Length19 Millimeter
Outer Diameter4.35 Millimeter
Length19 Millimeter
Outer Diameter4.35 Millimeter
Length19 Millimeter
Outer Diameter4.35 Millimeter
Length19 Millimeter
Outer Diameter4.35 Millimeter
Length19 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100889929025307 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889929025307]

Moist Heat or Steam Sterilization

[00889929025307]

Moist Heat or Steam Sterilization

[00889929025307]

Moist Heat or Steam Sterilization

[00889929025307]

Moist Heat or Steam Sterilization

[00889929025307]

Moist Heat or Steam Sterilization

[00889929025307]

Moist Heat or Steam Sterilization

[00889929025307]

Moist Heat or Steam Sterilization

[00889929025307]

Moist Heat or Steam Sterilization

[00889929025307]

Moist Heat or Steam Sterilization

[00889929025307]

Moist Heat or Steam Sterilization

[00889929025307]

Moist Heat or Steam Sterilization

[00889929025307]

Moist Heat or Steam Sterilization

[00889929025307]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-09-18
Device Publish Date2017-10-27

On-Brand Devices [Struxxure™ Anterior Cervical Plate and Screws]

00889929033067Lock Tool
00889929019436Drill Guide, Double Barrel, Fixed, 0°, Long
00889929019429Drill Guide, Double Barrel, Fixed, 15°, Long
00889929035245Drill Guide, Double Barrel, Fixed, 0°, Sideways, Assembly
00889929035238Drill Guide, Double Barrel, Fixed, 15°, Sideways, Assembly
00889929030127Struxxure, THR Screw Caddy, Fixed Self Tapping
00889929030110Struxxure, THR Screw Caddy, Variable Self Tapping
00889929028421Struxxure, THR Screw Caddy, Fixed Self Drilling
00889929028414Struxxure, THR Screw Caddy, Variable Self Drilling
00889929022863Fixed + Var Screw Caddy, Self-Tapping
00889929022856Fixed + Var Screw Caddy, Self-Drilling
00889929022849Fixed Self-Tapping Screw Caddy, Odd Length mm
00889929022832Variable Self-Tapping Screw Caddy, Odd Length mm
00889929019665Variable Self-Drilling Screw Caddy, Odd Length mm
00889929019658Fixed Self-Drilling Screw Caddy, Odd Length mm
00889929019641Struxxure Fixed Screw Caddy
00889929019634Struxxure Variable Screw Caddy
00889929019627Struxxure Self-Tapping Screw Caddy, Fixed, Even
00889929019610Struxxure Self-Tapping Screw Caddy, Variable, Even
00889929019603Struxxure Self-Drilling Screw Caddy, Fixed, Even
00889929019597Struxxure Self-Drilling Screw Caddy, Variable, Even
00889929019580Struxxure Fixed Screw Caddy
00889929019573Struxxure Variable Screw Caddy
00889929019566Struxxure Case
00889929019559Struxxure Plate Caddy, 5 Level
00889929019542Struxxure Plate Caddy, 4 Level
00889929019535Struxxure Plate Caddy, 3 Level
00889929019528Struxxure Plate Caddy, 2 Level
00889929019511Struxxure Plate Caddy, 1 Level
00889929047026THR Fixed Screw, Self Drilling, Ø4.0x20mm
00889929047019THR Variable Screw, Self Drilling, Ø4.0x20mm
00889929049075AC Plate, 3 Level, 76mm
00889929049068AC Plate, 3 Level, 74mm
00889929049051AC Plate, 3 Level, 70mm
00889929049044AC Plate, 3 Level, 68mm
00889929049037AC Plate, 3 Level, 64mm
00889929049020AC Plate, 3 Level, 62mm
00889929049013AC Plate, 3 Level, 58mm
00889929049006AC Plate, 3 Level, 56mm
00889929048993AC Plate, 3 Level, 52mm
00889929048986AC Plate, 3 Level, 50mm
00889929051337Fixed, Self-Tap, Screw Caddy
00889929051320Variable, Self-Tap, Screw Caddy
00889929051313Fixed, Self-Drill, Screw Caddy
00889929051306Variable, Self-Drill, Screw Caddy
00889929051818Corpectomy-Struxxure Implant & Instrument Case
00889929030936THR Fixed Screw, Self Tapping, Ø4.35x26mm
00889929030929THR Fixed Screw, Self Tapping, Ø4.0x26mm
00889929030912THR Variable Screw, Self Tapping, Ø4.35x26mm
00889929030905THR Variable Screw, Self Tapping, Ø4.0x26mm

Trademark Results [Struxxure]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STRUXXURE
STRUXXURE
86169608 4822921 Live/Registered
Nexxt Spine, LLC
2014-01-19
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.