HARRIER Choice Spine Intervertebral Body Device

GUDID 00840996157308

HARRIER,SHORT INSERTER SHAFT

Choice Spine, LP

Polymeric spinal interbody fusion cage
Primary Device ID00840996157308
NIH Device Record Key655922ff-ea59-448c-82a7-a83874e38c15
Commercial Distribution StatusIn Commercial Distribution
Brand NameHARRIER Choice Spine Intervertebral Body Device
Version Model NumberJ070-0045
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996157308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996157308]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2017-06-02

On-Brand Devices [HARRIER Choice Spine Intervertebral Body Device]

00840996157315HARRIER,SHORT ANT-LAT INSERTER SHEATH
00840996157308HARRIER,SHORT INSERTER SHAFT
00840996150125HARRIER,DISTRACTOR INSERTER

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.