NEXXT MATRIXX® Stand Alone ALIF System

GUDID 00889929044964

SA ALIF Trial, 30Dx40Wx8H, 8°

NEXXT SPINE, LLC

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit
Primary Device ID00889929044964
NIH Device Record Key96c0e4bb-f62d-4608-9bb1-b6b26ccd52f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameNEXXT MATRIXX® Stand Alone ALIF System
Version Model NumberI61-TR3040-08-08
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100889929044964 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889929044964]

Moist Heat or Steam Sterilization


[00889929044964]

Moist Heat or Steam Sterilization


[00889929044964]

Moist Heat or Steam Sterilization


[00889929044964]

Moist Heat or Steam Sterilization


[00889929044964]

Moist Heat or Steam Sterilization


[00889929044964]

Moist Heat or Steam Sterilization


[00889929044964]

Moist Heat or Steam Sterilization


[00889929044964]

Moist Heat or Steam Sterilization


[00889929044964]

Moist Heat or Steam Sterilization


[00889929044964]

Moist Heat or Steam Sterilization


[00889929044964]

Moist Heat or Steam Sterilization


[00889929044964]

Moist Heat or Steam Sterilization


[00889929044964]

Moist Heat or Steam Sterilization


[00889929044964]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-04
Device Publish Date2021-04-26

On-Brand Devices [NEXXT MATRIXX® Stand Alone ALIF System]

00889929043073SA ALIF, Implant Remover
00889929044230SA ALIF Fixed Angle Driver
00889929044056SA ALIF 25° Trial Caddy
00889929044049SA ALIF 30Dx40W Trial Caddy
00889929044032SA ALIF 27Dx36W Trial Caddy
00889929044025SA ALIF 24Dx32W Trial Caddy
00889929043929SA ALIF, Poly Awl
00889929043912SA ALIF, Guided Drill
00889929043905SA ALIF, Guided Angle Awl
00889929043899SA ALIF, Guided Straight Awl
00889929043882SA ALIF, Single Barrel Awl Guide
00889929043875Annulotomy Template, 40mm
00889929043868Annulotomy Template, 36mm
00889929043851Annulotomy Template, 32mm
00889929043844Annulotomy Centering Pin
00889929043837SA ALIF Trial, 30Dx40Wx20H, 25°
00889929043820SA ALIF Trial, 30Dx40Wx18H, 25°
00889929043813SA ALIF Trial, 30Dx40Wx16H, 25°
00889929043806SA ALIF Trial, 30Dx40Wx14H, 25°
00889929043790SA ALIF Trial, 30Dx40Wx20H, 20°
00889929043783SA ALIF Trial, 30Dx40Wx18H, 20°
00889929043776SA ALIF Trial, 30Dx40Wx16H, 20°
00889929043769SA ALIF Trial, 30Dx40Wx14H, 20°
00889929043752SA ALIF Trial, 30Dx40Wx20H, 14°
00889929043745SA ALIF Trial, 30Dx40Wx18H, 14°
00889929043738SA ALIF Trial, 30Dx40Wx16H, 14°
00889929043721SA ALIF Trial, 30Dx40Wx14H, 14°
00889929043714SA ALIF Trial, 30Dx40Wx12H, 14°
00889929043707SA ALIF Trial, 30Dx40Wx10H, 14°
00889929043691SA ALIF Trial, 30Dx40Wx18H, 8°
00889929043684SA ALIF Trial, 30Dx40Wx16H, 8°
00889929043677SA ALIF Trial, 30Dx40Wx14H, 8°
00889929043660SA ALIF Trial, 30Dx40Wx12H, 8°
00889929043653SA ALIF Trial, 30Dx40Wx10H, 8°
00889929043646SA ALIF Trial, 27Dx36Wx20H, 25°
00889929043639SA ALIF Trial, 27Dx36Wx18H, 25°
00889929043622SA ALIF Trial, 27Dx36Wx16H, 25°
00889929043615SA ALIF Trial, 27Dx36Wx14H, 25°
00889929043608SA ALIF Trial, 27Dx36Wx20H, 20°
00889929043592SA ALIF Trial, 27Dx36Wx18H, 20°
00889929043585SA ALIF Trial, 27Dx36Wx16H, 20°
00889929043578SA ALIF Trial, 27Dx36Wx14H, 20°
00889929043561SA ALIF Trial, 27Dx36Wx12H, 20°
00889929043554SA ALIF Trial, 27Dx36Wx20H, 14°
00889929043547SA ALIF Trial, 27Dx36Wx18H, 14°
00889929043530SA ALIF Trial, 27Dx36Wx16H, 14°
00889929043523SA ALIF Trial, 27Dx36Wx14H, 14°
00889929043516SA ALIF Trial, 27Dx36Wx12H, 14°
00889929043509SA ALIF Trial, 27Dx36Wx10H, 14°
00889929043493SA ALIF Trial, 27Dx36Wx18H, 8°

Trademark Results [NEXXT MATRIXX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NEXXT MATRIXX
NEXXT MATRIXX
87144687 5347347 Live/Registered
Nexxt Spine, LLC
2016-08-19

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