Thunderbolt & Lancer Pedicle Screw System

GUDID 00840996182409

THUNDERBOLT,BARREL CLAMP

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840996182409
NIH Device Record Key97f3a71f-6864-447f-944d-e198e526535b
Commercial Distribution StatusIn Commercial Distribution
Brand NameThunderbolt & Lancer Pedicle Screw System
Version Model NumberM070-0141
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
GS100840996182409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996182409]

Moist Heat or Steam Sterilization


[00840996182409]

Moist Heat or Steam Sterilization


[00840996182409]

Moist Heat or Steam Sterilization


[00840996182409]

Moist Heat or Steam Sterilization


[00840996182409]

Moist Heat or Steam Sterilization


[00840996182409]

Moist Heat or Steam Sterilization


[00840996182409]

Moist Heat or Steam Sterilization


[00840996182409]

Moist Heat or Steam Sterilization


[00840996182409]

Moist Heat or Steam Sterilization


[00840996182409]

Moist Heat or Steam Sterilization


[00840996182409]

Moist Heat or Steam Sterilization


[00840996182409]

Moist Heat or Steam Sterilization


[00840996182409]

Moist Heat or Steam Sterilization


[00840996182409]

Moist Heat or Steam Sterilization


[00840996182409]

Moist Heat or Steam Sterilization


[00840996182409]

Moist Heat or Steam Sterilization


[00840996182409]

Moist Heat or Steam Sterilization


[00840996182409]

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 & Lancer Pedicle Screw System]

00840996182416THUNDERBOLT,CLAMP DRIVER
00840996182409THUNDERBOLT,BARREL CLAMP

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