THUNDERBOLT Pedicle Screw System

GUDID 00840996182454

THUNDERBOLT,NAVIGATION AWL/TAP,4.5MM

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840996182454
NIH Device Record Keyb239e304-8173-4b04-9df0-7fe8039d3812
Commercial Distribution StatusIn Commercial Distribution
Brand NameTHUNDERBOLT Pedicle Screw System
Version Model NumberM070-2005
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996182454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996182454]

Moist Heat or Steam Sterilization


[00840996182454]

Moist Heat or Steam Sterilization


[00840996182454]

Moist Heat or Steam Sterilization


[00840996182454]

Moist Heat or Steam Sterilization


[00840996182454]

Moist Heat or Steam Sterilization


[00840996182454]

Moist Heat or Steam Sterilization


[00840996182454]

Moist Heat or Steam Sterilization


[00840996182454]

Moist Heat or Steam Sterilization


[00840996182454]

Moist Heat or Steam Sterilization


[00840996182454]

Moist Heat or Steam Sterilization


[00840996182454]

Moist Heat or Steam Sterilization


[00840996182454]

Moist Heat or Steam Sterilization


[00840996182454]

Moist Heat or Steam Sterilization


[00840996182454]

Moist Heat or Steam Sterilization


[00840996182454]

Moist Heat or Steam Sterilization


[00840996182454]

Moist Heat or Steam Sterilization


[00840996182454]

Moist Heat or Steam Sterilization


[00840996182454]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-14
Device Publish Date2023-07-06

On-Brand Devices [THUNDERBOLT Pedicle Screw System]

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

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