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 ID: 00840996161459
• NIH Device Record Key: 201c9db1-b602-41fd-bc45-f52f174b387a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THUNDERBOLT MI and LANCER Pedicle Screw System
• Version Model Number: MT40-DD10
• 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: true
• 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 Dimensions

• Length: 10.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996161459 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171456

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00840996161459]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-27

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

• 00840996161480: 5.5 DEFORMITY, INLINE CONNECTOR,ASSEMBLY
• 00840996161473: 5.5 DEFORM,DOMINO CONNECTOR, ASSEMBLY
• 00840996161466: 5.5 DEFORM,DOMINO CONNECTOR, ASSEMBLY
• 00840996161459: 5.5 DEFORM,DOMINO CONNECTOR, ASSEMBLY
• 00840996161442: 5.5 DEFORM,DOMINO CONNECTOR, ASSEMBLY