CHOICE SPINE LUMBAR SPACER SYSTEM

GUDID 00840996170635

LUMBAR,CURETTE,CUP,STRAIGHT,RIGHT,#2

Choice Spine, LP

Polymeric spinal interbody fusion cage
Primary Device ID00840996170635
NIH Device Record Key8a59caf9-4a72-4b35-bce8-369c5694d5ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameCHOICE SPINE LUMBAR SPACER SYSTEM
Version Model NumberP070-CUP02
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.net

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996170635 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996170635]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-24
Device Publish Date2018-03-22

On-Brand Devices [CHOICE SPINE LUMBAR SPACER SYSTEM]

00840996170666LUMBAR,CURETTE,CUP,69 DEG,PULL,#2
00840996170659LUMBAR,CURETTE,CUP,ANGLE,RIGHT,#2
00840996170642LUMBAR,CURETTE,CUP,ANGLE,LEFT,#2
00840996170635LUMBAR,CURETTE,CUP,STRAIGHT,RIGHT,#2
00840996170628LUMBAR,CURETTE,CUP,STRAIGHT,LEFT,#2

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