Harrier SA

GUDID 00840996177238

28x36x10,10deg Trial

Choice Spine, LP

Intervertebral-body internal spinal fixation system
Primary Device ID00840996177238
NIH Device Record Key8c9ac75e-bced-4980-b07b-f2ef3126a05f
Commercial Distribution StatusIn Commercial Distribution
Brand NameHarrier SA
Version Model NumberY070-28361010
Company DUNS078293017
Company NameChoice Spine, LP
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 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.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996177238 [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

[00840996177238]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-28
Device Publish Date2019-06-20

On-Brand Devices [Harrier SA]

00840996177245Harrier SA 26x32x8, 10 Deg
0084099617723828x36x10,10deg Trial
0084099617722128x36x8,10deg Trial
00840996184052HARRIER-SA,SCREW,5.5X40
00840996184045HARRIER-SA,SCREW,5.5X35
00840996184038HARRIER-SA,SCREW,5.5X30
00840996184021HARRIER-SA,SCREW,5.5X25
00840996184014HARRIER-SA,SCREW,5.5X20
00840996184007HARRIER-SA,SCREW,5.0x35
00840996183994HARRIER-SA,SCREW,5.0x40
00840996183987HARRIER-SA,SCREW,5.0x30
00840996183970HARRIER-SA,SCREW,5.0x25
00840996183963HARRIER-SA,SCREW,5.0x20
00840996192965HARRIER-SA,TRIAL,START WEDGE IMPACT 6H
00840996192958HARRIER-SA,TRIAL,START WEDGE IMPACT 8H

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