NeoFuse Ti3D PLIF/TLIF

GUDID 00818345021037

Ti3D CAGE 20L x 10W x 11H

HT MEDICAL, LLC

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage
Primary Device ID00818345021037
NIH Device Record Key126bbda5-3c2b-4c87-93ce-b859816b38e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeoFuse Ti3D PLIF/TLIF
Version Model NumberC2010-11
Company DUNS080386764
Company NameHT MEDICAL, 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com
Phone918-995-2090
Emailcustomerservice@htspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100818345021037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2017-11-07

On-Brand Devices [NeoFuse Ti3D PLIF/TLIF]

00818345021945Ti3D CAGE 32L x 12W x 18H
00818345021938Ti3D CAGE 32L x 12W x 17H
00818345021921Ti3D CAGE 32L x 12W x 16H
00818345021914Ti3D CAGE 32L x 12W x 15H
00818345021907Ti3D CAGE 32L x 12W x 14H
00818345021891Ti3D CAGE 32L x 12W x 13H
00818345021884Ti3D CAGE 32L x 12W x 12H
00818345021877Ti3D CAGE 32L x 12W x 11H
00818345021860Ti3D CAGE 32L x 12W x 10H
00818345021853Ti3D CAGE 32L x 12W x 9H
00818345021846Ti3D CAGE 32L x 12W x 8H
00818345021839Ti3D CAGE 32L x 12W x 7H
00818345021822Ti3D CAGE 30L x 12W x 18H
00818345021815Ti3D CAGE 30L x 12W x 17H
00818345021808Ti3D CAGE 30L x 12W x 16H
00818345021792Ti3D CAGE 30L x 12W x 15H
00818345021785Ti3D CAGE 30L x 12W x 14H
00818345021778Ti3D CAGE 30L x 12W x 13H
00818345021761Ti3D CAGE 30L x 12W x 12H
00818345021754Ti3D CAGE 30L x 12W x 11H
00818345021747Ti3D CAGE 30L x 12W x 10H
00818345021730Ti3D CAGE 30L x 12W x 9H
00818345021723Ti3D CAGE 30L x 12W x 8H
00818345021716Ti3D CAGE 30L x 12W x 7H
00818345021709Ti3D CAGE 24L x 12W x 18H
00818345021693Ti3D CAGE 24L x 12W x 17H
00818345021686Ti3D CAGE 24L x 12W x 16H
00818345021679Ti3D CAGE 24L x 12W x 15H
00818345021662Ti3D CAGE 24L x 12W x 14H
00818345021655Ti3D CAGE 24L x 12W x 13H
00818345021648Ti3D CAGE 24L x 12W x 12H
00818345021631Ti3D CAGE 24L x 12W x 11H
00818345021624Ti3D CAGE 24L x 12W x 10H
00818345021617Ti3D CAGE 24L x 12W x 9H
00818345021600Ti3D CAGE 24L x 12W x 8H
00818345021594Ti3D CAGE 24L x 12W x 7H
00818345021587Ti3D CAGE 20L x 12W x 18H
00818345021570Ti3D CAGE 20L x 12W x 17H
00818345021563Ti3D CAGE 20L x 12W x 16H
00818345021556Ti3D CAGE 20L x 12W x 15H
00818345021549Ti3D CAGE 20L x 12W x 14H
00818345021532Ti3D CAGE 20L x 12W x 13H
00818345021525Ti3D CAGE 20L x 12W x 12H
00818345021518Ti3D CAGE 20L x 12W x 11H
00818345021501Ti3D CAGE 20L x 12W x 10H
00818345021495Ti3D CAGE 20L x 12W x 9H
00818345021488Ti3D CAGE 20L x 12W x 8H
00818345021471Ti3D CAGE 20L x 12W x 7H
00818345021464Ti3D CAGE 32L x 10W x 18H
00818345021457Ti3D CAGE 32L x 10W x 17H

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