SCS CLARIS Spinal System

GUDID 00840996163668

SCS,DRIVER,FINAL TIGHTENING

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840996163668
NIH Device Record Key64710fd0-aacb-4f7f-b86d-eb546850f30a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSCS CLARIS Spinal System
Version Model Number1070-1012
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
GS100840996163668 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, spondylolisthesis spinal fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996163668]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-09-13

On-Brand Devices [SCS CLARIS Spinal System]

00840996174695UNIV,T HANDLE, TORQUE,90,SQUARE
00840996174404UNIV,ROD BENDER,FRENCH
00840996163675SCS,DRIVER SHAFT,POLYAXIAL
00840996163668SCS,DRIVER,FINAL TIGHTENING
00840996122924CLARIS,CONNECTOR,OMNIAXIAL,EXTEND,LONG
00840996122917CLARIS,CONNECTOR,OMNIAXIAL,EXTEND,MED
00840996122894CLARIS,CONNECTOR,LATERAL,LONG,M6
00840996122887CLARIS,CONNECTOR,LATERAL,EXTREMITY,M6
00840996122870CLARIS,CONNECTOR,LATERAL,EXTREMITY
00840996122863CLARIS,CONNECTOR,LATERAL,LONG,EXTREMITY
00840996122856CLARIS,CONNECTOR,LATERAL
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