HARRIER-SA Lumbar Interbody System

GUDID 00840996187565

HARRIER-SA,STARTER TRIAL,8H26X32,WEDGE

Choice Spine, LP

Intervertebral-body internal spinal fixation system
Primary Device ID00840996187565
NIH Device Record Key535be951-9e0e-47ab-9457-c6e942c6e6b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameHARRIER-SA Lumbar Interbody System
Version Model NumberY070-26321308W
Company DUNS078293017
Company NameChoice Spine, LP
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

Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996187565 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic manual surgical instrument
OVDIntervertebral fusion device with integrated fixation, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

[00840996187565]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-13
Device Publish Date2023-02-03

On-Brand Devices [HARRIER-SA Lumbar Interbody System]

00840996177399HARRIER-SA,TRIAL,STARTER
00840996177078HARRIER-SA,SCREW,5.0X60MM
00840996177061HARRIER-SA,SCREW,5.0X55MM
00840996177054HARRIER-SA,SCREW,5.0X50MM
00840996177047HARRIER-SA,SCREW,5.0X45MM
00840996177030HARRIER-SA,SCREW,5.5X60
00840996177023HARRIER-SA,SCREW,5.5X55
00840996177016HARRIER-SA,SCREW,5.5X50
00840996177009HARRIER-SA,SCREW,5.5X45
00840996174718HARRIER-SA,INSERTER
00840996174572HARRIER-SA,GRAFT BLOCK
00840996174565HARRIER-SA,MALLET
00840996174473HARRIER-SA,COVERPLATE,ZERO,ASSY,23
00840996174466HARRIER-SA,COVERPLATE,ZERO,ASSY,21
00840996174459HARRIER-SA,COVERPLATE,ZERO,ASSY,19
00840996174442HARRIER-SA,COVERPLATE,ZERO,ASSY,17
00840996174435HARRIER-SA,COVERPLATE,ZERO,ASSY,15
00840996174428HARRIER-SA,COVERPLATE,ZERO,ASSY,13
00840996174411HARRIER-SA,COVERPLATE,ZERO,ASSY,12
00840996174398HARRIER-SA,AWL,VARIABLE,ANGLE
00840996174381HARRIER-SA,DRIVER,VARAIBLE,ANGLE
00840996174374HARRIER-SA,AWL GUIDE
00840996173629HARRIER-SA,STRAIGHT DRIVER
00840996173612HARRIER-SA,STRAIGHT AWL
00840996173605HARRIER-SA,DRIVER,FIXED,ANGLE
00840996173599HARRIER-SA,ANGLED AWL
00840996173575HARRIER-SA,RETRACTABLE AWL
00840996173568HARRIER-SA,SPREADER
00840996173551HARRIER-SA,TRIAL,28x36x23,30 DEG
00840996173544HARRIER-SA,TRIAL,28x36x21,30 DEG
00840996173537HARRIER-SA,TRIAL,28x36x19,30 DEG
00840996173520HARRIER-SA,TRIAL,28x36x21,25 DEG
00840996173513HARRIER-SA,TRIAL,28x36x19,25 DEG
00840996173506HARRIER-SA,TRIAL,28x36x17,25 DEG
00840996173490HARRIER-SA,TRIAL,28x36x15,25 DEG
00840996173483HARRIER-SA,TRIAL,28x36x19,20 DEG
00840996173476HARRIER-SA,TRIAL,28x36x17,20 DEG
00840996173469HARRIER-SA,TRIAL,28x36x15,20 DEG
00840996173452HARRIER-SA,TRIAL,28x36x13,20 DEG
00840996173445HARRIER-SA,TRIAL,28x36x19,15 DEG
00840996173438HARRIER-SA,TRIAL,28x36x17,15 DEG
00840996173421HARRIER-SA,TRIAL,28x36x15,15 DEG
00840996173414HARRIER-SA,TRIAL,28x36x13,15 DEG
00840996173407HARRIER-SA,TRIAL,28x36x12,15 DEG
00840996173391HARRIER-SA,TRIAL,28x36x19,10 DEG
00840996173384HARRIER-SA,TRIAL,28x36x17,10 DEG
00840996173377HARRIER-SA,TRIAL,28x36x15,10 DEG
00840996173360HARRIER-SA,TRIAL,28x36x13,10 DEG
00840996173353HARRIER-SA,TRIAL,28x36x12,10 DEG
00840996173346HARRIER-SA,TRIAL,26x32x19,15 DEG
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