Thunderbolt Pedicle Screw System

GUDID 00840996177214

Thunderbolt Decorticator

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840996177214
NIH Device Record Key91ae33de-e079-4f1b-a026-b3c3fc879131
Commercial Distribution StatusIn Commercial Distribution
Brand NameThunderbolt Pedicle Screw System
Version Model NumberM070-0132
Company DUNS078293017
Company NameChoice Spine, LP
Device Count1
DM Exempttrue
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.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996177214 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996177214]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-28
Device Publish Date2019-06-20

On-Brand Devices [Thunderbolt Pedicle Screw System]

00840996177214Thunderbolt Decorticator
00840996182454THUNDERBOLT,NAVIGATION AWL/TAP,4.5MM

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