THUNDERBOLT Minimally Invasive Pedicle Screw System

GUDID 00840996175043

THUNDERBOLT,REDUCER,LARGE T

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840996175043
• NIH Device Record Key: fe6496dc-87f8-4d5d-b7e7-bba0027c888f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THUNDERBOLT Minimally Invasive Pedicle Screw System
• Version Model Number: M070-0131
• Company DUNS: 078293017
• Company Name: Choice Spine, LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(865)246-3333
• Email: info@choicespine.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996175043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171456

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840996175043]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-03
• Device Publish Date: 2018-11-02

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

• 00840996175050: THUNDERBOLT,ROD CALIPER,SIDE MARKED
• 00840996175043: THUNDERBOLT,REDUCER,LARGE T
• 00840996175036: THUNDERBOLT,EXTERNAL REDUCER
• 00840996171250: THUNDERBOLT,UNIVERSAL SCREWDRIVER
• 00840996170703: THUNDERBOLT,TAP,7.5,40DEG TIP
• 00840996170697: THUNDERBOLT,TAP,6.5,40DEG TIP
• 00840996170680: THUNDERBOLT,TAP,5.5,40DEG TIP
• 00840996192859: THUNDERBOLT,7.0 TAP FOR 7.5 SCREW
• 00840996192842: THUNDERBOLT,6.0 TAP FOR 6.5 SCREW
• 00840996192835: THUNDERBOLT,5.0 TAP FOR 5.5 SCREW
• 00840996192828: THUNDERBOLT,4.0 TAP FOR 4.5 SCREW
• 00840996188258: THUNDERBOLT,1/4 SQUARE SET SCREW DRIVER
• 00840996187862: TBOLT,UNIVERSAL SCREWDRIVER, NEW THREAD