SCS Spinal System

GUDID 00840996122382

SCS,HOOK,TRANSVERSE

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840996122382
NIH Device Record Key63f896d2-5221-4ef6-99a4-a1d4973becf4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSCS Spinal System
Version Model Number2T20-CT04
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 Usetrue
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
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
GS100840996122382 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

[00840996122382]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [SCS Spinal System]

00840996122955CLARIS,CONNECTOR,OMNIAXIAL,LONG
00840996122948CLARIS,CONNECTOR,OMNIAXIAL,MEDIUM
00840996122931CLARIS,CONNECTOR,OMNIAXIAL,SHORT
00840996122900CLARIS,CONNECTOR,OMNIAXIAL
00840996122788CLARIS,CONNECTOR,ANTERIOR
00840996122504SCS,ROD,TRANSVERSE
00840996122481SCS,CONNECTOR,SLEEVE,5.5X6.0
00840996122474SCS,CONNECTION TUBE,LENGTHENED
00840996122467SCS,CONNECTION TUBE
00840996122450SCS,CONNECTOR,MIXED JUNCTION
00840996122443SCS,CONNECTOR,CLOSED JUNCTION,DOMINO
00840996122436SCS,CONNECTOR,CLOSED JUNCTION,LARGE
00840996122429SCS,CONNECTOR,CLOSED JUNCTION
00840996122405SCS,CONNECTOR,TRANSVERSE
00840996122399SCS,HOOK,TRANSVERSE,SMALL
00840996122382SCS,HOOK,TRANSVERSE
00840996122375SCS,HOOK,PEDICLE,SMALL
00840996122368SCS,HOOK,PEDICLE,MEDIUM
00840996122351SCS,HOOK,PEDICLE
00840996122344SCS,HOOK,LAMINAR,MEDIUM
00840996122337SCS,HOOK,LAMINAR,SMALL
00840996122320SCS,HOOK,LAMINAR,INFRA
00840996122313SCS,HOOK,LAMINAR,SUPRA
00840996122306SCS,HOOK,LAMINAR,LENGTHENED BODY
00840996122290SCS,HOOK,LAMINAR SUPRA
00840996122283SCS,HOOK,LAMINAR
00840996122276SCS,HOOK,MEDIUM RIGHT OFFSET LAMINAR
00840996122269SCS,HOOK,MEDIUM LEFT OFFSET LAMINAR
00840996122252SCS,HOOK,SMALL RIGHT OFFSET LAMINAR
00840996122245SCS,HOOK,SMALL LEFT OFFSET LAMINAR
00840996122238SCS,HOOK,RIGHT OFFSET LAMINAR
00840996122221SCS,HOOK,LEFT OFFSET LAMINAR
00840996122214SCS,HOOK,RIGHT OFFSET THORACIC
00840996122207SCS,HOOK,LEFT OFFSET THORACIC
00840996122191SCS,CONNECTOR,INTERMEDIATE
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