THUNDERBOLT Minimally Invasive Pedicle Screw System

GUDID 00840996170680

THUNDERBOLT,TAP,5.5,40DEG TIP

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840996170680
NIH Device Record Keya566db01-f79e-453f-977c-2ad6449b2846
Commercial Distribution StatusIn Commercial Distribution
Brand NameTHUNDERBOLT Minimally Invasive Pedicle Screw System
Version Model NumberM070-0123
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
GS100840996170680 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996170680]

Moist Heat or Steam Sterilization

[00840996170680]

Moist Heat or Steam Sterilization

[00840996170680]

Moist Heat or Steam Sterilization

[00840996170680]

Moist Heat or Steam Sterilization

[00840996170680]

Moist Heat or Steam Sterilization

[00840996170680]

Moist Heat or Steam Sterilization

[00840996170680]

Moist Heat or Steam Sterilization

[00840996170680]

Moist Heat or Steam Sterilization

[00840996170680]

Moist Heat or Steam Sterilization

[00840996170680]

Moist Heat or Steam Sterilization

[00840996170680]

Moist Heat or Steam Sterilization

[00840996170680]

Moist Heat or Steam Sterilization

[00840996170680]

Moist Heat or Steam Sterilization

[00840996170680]

Moist Heat or Steam Sterilization

[00840996170680]

Moist Heat or Steam Sterilization

[00840996170680]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-06

On-Brand Devices [THUNDERBOLT Minimally Invasive Pedicle Screw System]

00840996175050THUNDERBOLT,ROD CALIPER,SIDE MARKED
00840996175043THUNDERBOLT,REDUCER,LARGE T
00840996175036THUNDERBOLT,EXTERNAL REDUCER
00840996171250THUNDERBOLT,UNIVERSAL SCREWDRIVER
00840996170703THUNDERBOLT,TAP,7.5,40DEG TIP
00840996170697THUNDERBOLT,TAP,6.5,40DEG TIP
00840996170680THUNDERBOLT,TAP,5.5,40DEG TIP
00840996192859THUNDERBOLT,7.0 TAP FOR 7.5 SCREW
00840996192842THUNDERBOLT,6.0 TAP FOR 6.5 SCREW
00840996192835THUNDERBOLT,5.0 TAP FOR 5.5 SCREW
00840996192828THUNDERBOLT,4.0 TAP FOR 4.5 SCREW
00840996188258THUNDERBOLT,1/4 SQUARE SET SCREW DRIVER
00840996187862TBOLT,UNIVERSAL SCREWDRIVER, NEW THREAD
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