THUNDERBOLT MI and LANCER Pedicle Screw System

GUDID 00840996161459

5.5 DEFORM,DOMINO CONNECTOR, ASSEMBLY

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840996161459
NIH Device Record Key201c9db1-b602-41fd-bc45-f52f174b387a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTHUNDERBOLT MI and LANCER Pedicle Screw System
Version Model NumberMT40-DD10
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

Device Dimensions

Length10.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996161459 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996161459]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-01-27

On-Brand Devices [THUNDERBOLT MI and LANCER Pedicle Screw System]

008409961614805.5 DEFORMITY, INLINE CONNECTOR,ASSEMBLY
008409961614735.5 DEFORM,DOMINO CONNECTOR, ASSEMBLY
008409961614665.5 DEFORM,DOMINO CONNECTOR, ASSEMBLY
008409961614595.5 DEFORM,DOMINO CONNECTOR, ASSEMBLY
008409961614425.5 DEFORM,DOMINO CONNECTOR, ASSEMBLY

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