THUNDERBOLT Minimally Invasive and Lancer Open Pedicle Screw Systems

GUDID 00840996175616

THUNDERBOLT,T-HANDLE,REDUCER

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840996175616
NIH Device Record Key83170c3b-e9d9-42af-832c-f891fb78cc94
Commercial Distribution StatusIn Commercial Distribution
Brand NameTHUNDERBOLT Minimally Invasive and Lancer Open Pedicle Screw Systems
Version Model NumberM070-0131A
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
GS100840996175616 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996175616]

Moist Heat or Steam Sterilization

[00840996175616]

Moist Heat or Steam Sterilization

[00840996175616]

Moist Heat or Steam Sterilization

[00840996175616]

Moist Heat or Steam Sterilization

[00840996175616]

Moist Heat or Steam Sterilization

[00840996175616]

Moist Heat or Steam Sterilization

[00840996175616]

Moist Heat or Steam Sterilization

[00840996175616]

Moist Heat or Steam Sterilization

[00840996175616]

Moist Heat or Steam Sterilization

[00840996175616]

Moist Heat or Steam Sterilization

[00840996175616]

Moist Heat or Steam Sterilization

[00840996175616]

Moist Heat or Steam Sterilization

[00840996175616]

Moist Heat or Steam Sterilization

[00840996175616]

Moist Heat or Steam Sterilization

[00840996175616]

Moist Heat or Steam Sterilization

[00840996175616]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-24
Device Publish Date2018-11-21

Devices Manufactured by Choice Spine, LP

00840996176552 - BOOMERANG2026-01-23 BOOMERANG SELF DRILLING SCREWS 4.54X 13
00840996176569 - BOOMERANG2026-01-23 BOOMERANG,SCREW,SELF-DRILLING,4.5X15
00840996176576 - Boomerang2026-01-23 BOOMERANG SELF DRILLING SCREWS 4.54X 17
00840996176583 - BOOMERANG2026-01-23 BOOMERANG PLATE HOLDER
00840996176590 - BOOMERANG2026-01-23 BOOMERANG DRILL, 10MM
00840996176606 - Boomerang2026-01-23 Boomerang Combination Drill/Awl AO
00840996182119 - HARRIER-SA Lumbar Interbody System2024-03-05 HARRIER-SA,DRIVER,SPLIT-TIP
00840996150682 - Acapella One2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X5
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