LANCER/THUNDERBOLT Pedicle Screw System

GUDID 00840996148504

LANCER,CANN,TAP11.5

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840996148504
NIH Device Record Keyf3b957a2-d4b0-4ce3-b39a-2698b97a7824
Commercial Distribution StatusIn Commercial Distribution
Brand NameLANCER/THUNDERBOLT Pedicle Screw System
Version Model NumberM070-0110
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
GS100840996148504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWXTAP, BONE
LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996148504]

Moist Heat or Steam Sterilization

[00840996148504]

Moist Heat or Steam Sterilization

[00840996148504]

Moist Heat or Steam Sterilization

[00840996148504]

Moist Heat or Steam Sterilization

[00840996148504]

Moist Heat or Steam Sterilization

[00840996148504]

Moist Heat or Steam Sterilization

[00840996148504]

Moist Heat or Steam Sterilization

[00840996148504]

Moist Heat or Steam Sterilization

[00840996148504]

Moist Heat or Steam Sterilization

[00840996148504]

Moist Heat or Steam Sterilization

[00840996148504]

Moist Heat or Steam Sterilization

[00840996148504]

Moist Heat or Steam Sterilization

[00840996148504]

Moist Heat or Steam Sterilization

[00840996148504]

Moist Heat or Steam Sterilization

[00840996148504]

Moist Heat or Steam Sterilization

[00840996148504]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-17

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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