THUNDERBOLT Minimally Invasive Pedicle Screw Systems

GUDID 00840996148931

THUNDERBOLT,SCREW,POLYAXIAL,12.5X75

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840996148931
NIH Device Record Keye99f4b9f-7290-406d-b50a-37c69d133290
Commercial Distribution StatusIn Commercial Distribution
Brand NameTHUNDERBOLT Minimally Invasive Pedicle Screw Systems
Version Model NumberMT10-12575
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 Usetrue
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 Dimensions

Length75 Millimeter
Outer Diameter12.5 Millimeter
Length75 Millimeter
Outer Diameter12.5 Millimeter
Length75 Millimeter
Outer Diameter12.5 Millimeter
Length75 Millimeter
Outer Diameter12.5 Millimeter
Length75 Millimeter
Outer Diameter12.5 Millimeter
Length75 Millimeter
Outer Diameter12.5 Millimeter
Length75 Millimeter
Outer Diameter12.5 Millimeter
Length75 Millimeter
Outer Diameter12.5 Millimeter
Length75 Millimeter
Outer Diameter12.5 Millimeter
Length75 Millimeter
Outer Diameter12.5 Millimeter
Length75 Millimeter
Outer Diameter12.5 Millimeter
Length75 Millimeter
Outer Diameter12.5 Millimeter
Length75 Millimeter
Outer Diameter12.5 Millimeter
Length75 Millimeter
Outer Diameter12.5 Millimeter
Length75 Millimeter
Outer Diameter12.5 Millimeter
Length75 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996148931 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996148931]

Moist Heat or Steam Sterilization

[00840996148931]

Moist Heat or Steam Sterilization

[00840996148931]

Moist Heat or Steam Sterilization

[00840996148931]

Moist Heat or Steam Sterilization

[00840996148931]

Moist Heat or Steam Sterilization

[00840996148931]

Moist Heat or Steam Sterilization

[00840996148931]

Moist Heat or Steam Sterilization

[00840996148931]

Moist Heat or Steam Sterilization

[00840996148931]

Moist Heat or Steam Sterilization

[00840996148931]

Moist Heat or Steam Sterilization

[00840996148931]

Moist Heat or Steam Sterilization

[00840996148931]

Moist Heat or Steam Sterilization

[00840996148931]

Moist Heat or Steam Sterilization

[00840996148931]

Moist Heat or Steam Sterilization

[00840996148931]

Moist Heat or Steam Sterilization

[00840996148931]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-23

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

00840996160681TBOLT,ROD,PREBENT,TI,5.5X140
00840996148979THUNDERBOLT,SCREW,POLYAXIAL,12.5X110
00840996148962THUNDERBOLT,SCREW,POLYAXIAL,12.5X100
00840996148955THUNDERBOLT,SCREW,POLYAXIAL,12.5X90
00840996148948THUNDERBOLT,SCREW,POLYAXIAL,12.5X80
00840996148931THUNDERBOLT,SCREW,POLYAXIAL,12.5X75
00840996148924THUNDERBOLT,SCREW,POLYAXIAL,12.5X70
00840996148917THUNDERBOLT,SCREW,POLYAXIAL,12.5X65
00840996148900THUNDERBOLT,SCREW,POLYAXIAL,12.5X60
00840996148894THUNDERBOLT,SCREW,POLYAXIAL,12.5X55
00840996148887THUNDERBOLT,SCREW,POLYAXIAL,12.5X50
00840996148870THUNDERBOLT,SCREW,POLYAXIAL,12.5X45
00840996148863THUNDERBOLT,SCREW,POLYAXIAL,12.5X40
00840996148856THUNDERBOLT,SCREW,POLYAXIAL,12.5X35
00840996148849THUNDERBOLT,SCREW,POLYAXIAL,12.5X30
00840996148832THUNDERBOLT,SCREW,POLYAXIAL,12.5X25
00840996148825THUNDERBOLT,SCREW,POLYAXIAL,11.5X110
00840996148818THUNDERBOLT,SCREW,POLYAXIAL,11.5X100
00840996148801THUNDERBOLT,SCREW,POLYAXIAL,11.5X90
00840996148795THUNDERBOLT,SCREW,POLYAXIAL,11.5X80
00840996148788THUNDERBOLT,SCREW,POLYAXIAL,11.5X75
00840996148771THUNDERBOLT,SCREW,POLYAXIAL,11.5X70
00840996148764THUNDERBOLT,SCREW,POLYAXIAL,11.5X65
00840996148757THUNDERBOLT,SCREW,POLYAXIAL,11.5X60
00840996148740THUNDERBOLT,SCREW,POLYAXIAL,11.5X55
00840996148733THUNDERBOLT,SCREW,POLYAXIAL,11.5X50
00840996148726THUNDERBOLT,SCREW,POLYAXIAL,11.5X45
00840996148719THUNDERBOLT,SCREW,POLYAXIAL,11.5X40
00840996148702THUNDERBOLT,SCREW,POLYAXIAL,11.5X35
00840996148696THUNDERBOLT,SCREW,POLYAXIAL,11.5X30
00840996148689THUNDERBOLT,SCREW,POLYAXIAL,11.5X25
00840996148672THUNDERBOLT,SCREW,POLYAXIAL,10.5x110
00840996148665THUNDERBOLT,SCREW,POLYAXIAL,10.5x100
00840996148658THUNDERBOLT,SCREW,POLYAXIAL,10.5x90
00840996148641THUNDERBOLT,SCREW,POLYAXIAL,10.5x80
00840996148634THUNDERBOLT,SCREW,POLYAXIAL,10.5x75
00840996148627THUNDERBOLT,SCREW,POLYAXIAL,10.5x70
00840996148610THUNDERBOLT,SCREW,POLYAXIAL,10.5x65
00840996148603THUNDERBOLT,SCREW,POLYAXIAL,10.5x60
00840996148597THUNDERBOLT,SCREW,POLYAXIAL,10.5x55
00840996148580THUNDERBOLT,SCREW,POLYAXIAL,10.5x50
00840996148573THUNDERBOLT,SCREW,POLYAXIAL,10.5x45
00840996148566THUNDERBOLT,SCREW,POLYAXIAL,10.5x40
00840996148559THUNDERBOLT,SCREW,POLYAXIAL,10.5x35
00840996148542THUNDERBOLT,SCREW,POLYAXIAL,10.5x30
00840996148535THUNDERBOLT,SCREW,POLYAXIAL,10.5X25
00840996188722TBOLT,ROD,PREBENT,TI,5.5X200
00840996188715TBOLT,ROD,PREBENT,TI,5.5X195
00840996188708TBOLT,ROD,PREBENT,TI,5.5X190
00840996188692TBOLT,ROD,PREBENT,TI,5.5X185
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.