Thunderbolt Pedicle Screw System

GUDID 00840996177214

Thunderbolt Decorticator

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840996177214
• NIH Device Record Key: 91ae33de-e079-4f1b-a026-b3c3fc879131
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thunderbolt Pedicle Screw System
• Version Model Number: M070-0132
• Company DUNS: 078293017
• Company Name: Choice Spine, LP
• Device Count: 1
• DM Exempt: true
• 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.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996177214 [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

[00840996177214]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-28
• Device Publish Date: 2019-06-20

On-Brand Devices [Thunderbolt Pedicle Screw System]

• 00840996177214: Thunderbolt Decorticator
• 00840996182454: THUNDERBOLT,NAVIGATION AWL/TAP,4.5MM