LANCER/THUNDERBOLT Pedicle Screw System

GUDID 00840996173889

T'BOLT,KWIRE,SS,TROCAR-TROCAR,LASER,20

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840996173889
NIH Device Record Key874fe0ee-4b75-4487-a332-bbfaedb8c278
Commercial Distribution StatusIn Commercial Distribution
Brand NameLANCER/THUNDERBOLT Pedicle Screw System
Version Model NumberM070-LS320
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
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
GS100840996173889 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996173889]

Moist Heat or Steam Sterilization

[00840996173889]

Moist Heat or Steam Sterilization

[00840996173889]

Moist Heat or Steam Sterilization

[00840996173889]

Moist Heat or Steam Sterilization

[00840996173889]

Moist Heat or Steam Sterilization

[00840996173889]

Moist Heat or Steam Sterilization

[00840996173889]

Moist Heat or Steam Sterilization

[00840996173889]

Moist Heat or Steam Sterilization

[00840996173889]

Moist Heat or Steam Sterilization

[00840996173889]

Moist Heat or Steam Sterilization

[00840996173889]

Moist Heat or Steam Sterilization

[00840996173889]

Moist Heat or Steam Sterilization

[00840996173889]

Moist Heat or Steam Sterilization

[00840996173889]

Moist Heat or Steam Sterilization

[00840996173889]

Moist Heat or Steam Sterilization

[00840996173889]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-27
Device Publish Date2018-07-25

On-Brand Devices [LANCER/THUNDERBOLT Pedicle Screw System]

00840996176118TBOLT,KWIRE,SS,TROCAR-TROCAR,THRD,24"
00840996176101TBOLT,KWIRE,SS,TROCAR-TROCAR,THRD,22"
00840996176095TBOLT,KWIRE,SS,TROCAR-TROCAR,THRD,20"
00840996176088TBOLT,KWIRE,SS,TROCAR-TROCAR,THRD,18"
00840996176071TBOLT,KWIRE,SS,TROCAR-TROCAR,THRD,12"
00840996176064TBOLT,KWIRE,SS,BLUNT-TROCAR,THRD,24"
00840996176057TBOLT,KWIRE,SS,BLUNT-TROCAR,THRD,22"
00840996176040TBOLT,KWIRE,SS,BLUNT-TROCAR,THRD,20"
00840996176033TBOLT,KWIRE,SS,BLUNT-TROCAR,THRD,18"
00840996176026TBOLT,KWIRE,SS,BLUNT-TROCAR,THRD,12"
00840996176019TBOLT,KWIRE,SS,BLUNT-BLUNT,THRD,24"
00840996176002TBOLT,KWIRE,SS,BLUNT-BLUNT,THRD,22"
00840996175999TBOLT,KWIRE,SS,BLUNT-BLUNT,THRD,20"
00840996175982TBOLT,KWIRE,SS,BLUNT-BLUNT,THRD,18"
00840996175975TBOLT,KWIRE,SS,BLUNT-BLUNT,THRD,12"
00840996175968TBOLT,KWIRE,NIT.,TROCAR-TROCAR,THRD,24"
00840996175951TBOLT,KWIRE,NIT.,TROCAR-TROCAR,THRD,22"
00840996175944TBOLT,KWIRE,NIT.,TROCAR-TROCAR,THRD,20"
00840996175937TBOLT,KWIRE,NIT.,TROCAR-TROCAR,THRD,18"
00840996175920TBOLT,KWIRE,NIT.,TROCAR-TROCAR,THRD,12"
00840996175913TBOLT,KWIRE,NIT.,BLUNT-TROCAR,THRD,24"
00840996175906TBOLT,KWIRE,NIT.,BLUNT-TROCAR,THRD,22"
00840996175890TBOLT,KWIRE,NIT.,BLUNT-TROCAR,THRD,20"
00840996175883TBOLT,KWIRE,NIT.,BLUNT-TROCAR,THRD,18"
00840996175876TBOLT,KWIRE,NIT.,BLUNT-TROCAR,THRD,12"
00840996175869TBOLT,KWIRE,NIT.,BLUNT-BLUNT,THRD,24"
00840996175852TBOLT,KWIRE,NIT.,BLUNT-BLUNT,THRD,22"
00840996175845TBOLT,KWIRE,NIT.,BLUNT-BLUNT,THRD,20"
00840996175838TBOLT,KWIRE,NIT.,BLUNT-BLUNT,THRD,18"
00840996175821TBOLT,KWIRE,NIT.,BLUNT-BLUNT,THRD,12"
00840996174039NAVIGATION,FIELD BLOCK
00840996174022NAVIGATION,FIELD PROBE
00840996173902T'BOLT,KWIRE,SS,TROCAR-TROCAR,LASER,24
00840996173896T'BOLT,KWIRE,SS,TROCAR-TROCAR,LASER,22
00840996173889T'BOLT,KWIRE,SS,TROCAR-TROCAR,LASER,20
00840996173872T'BOLT,KWIRE,SS,TROCAR-TROCAR,LASER,12
00840996173865T'BOLT,KWIRE,SS,BLUNT-TROCAR,LASER,24
00840996173858T'BOLT,KWIRE,SS,BLUNT-TROCAR,LASER,22
00840996173841T'BOLT,KWIRE,SS,BLUNT-TROCAR,LASER,20
00840996173834T'BOLT,KWIRE,SS,BLUNT-TROCAR,LASER,12
00840996173827T'BOLT,KWIRE,SS,BLUNT-BLUNT,LASER,24
00840996173810T'BOLT,KWIRE,SS,BLUNT-BLUNT,LASER,22
00840996173803T'BOLT,KWIRE,SS,BLUNT-BLUNT,LASER,20
00840996173797T'BOLT,KWIRE,SS,BLUNT-BLUNT,LASER,12
00840996173780TBOLT,KWIRE,NITOL,TROCAR-TROCAR,LASER,24
00840996173773TBOLT,KWIRE,NITOL,TROCAR-TROCAR,LASER,22
00840996173766TBOLT,KWIRE,NITOL,TROCAR-TROCAR,LASER,20
00840996173759TBOLT,KWIRE,NITOL,TROCAR-TROCAR,LASER,12
00840996173742T'BOLT,KWIRE,NITOL,BLUNT-TROCAR,LASER,24
00840996173735T'BOLT,KWIRE,NITOL,BLUNT-TROCAR,LASER,22
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