LANCER & THUNDERBOLT PEDICLE SCREW SYSTEM

GUDID 00840996192996

THUNDERBOLT,C/D FULCRUM

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840996192996
• NIH Device Record Key: da2386f5-1575-40e6-8af8-302906e01d6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LANCER & THUNDERBOLT PEDICLE SCREW SYSTEM
• Version Model Number: M070-0149-TB
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996192996 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132049

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[00840996192996]

Moist Heat or Steam Sterilization

[00840996192996]

Moist Heat or Steam Sterilization

[00840996192996]

Moist Heat or Steam Sterilization

[00840996192996]

Moist Heat or Steam Sterilization

[00840996192996]

Moist Heat or Steam Sterilization

[00840996192996]

Moist Heat or Steam Sterilization

[00840996192996]

Moist Heat or Steam Sterilization

[00840996192996]

Moist Heat or Steam Sterilization

[00840996192996]

Moist Heat or Steam Sterilization

[00840996192996]

Moist Heat or Steam Sterilization

[00840996192996]

Moist Heat or Steam Sterilization

[00840996192996]

Moist Heat or Steam Sterilization

[00840996192996]

Moist Heat or Steam Sterilization

[00840996192996]

Moist Heat or Steam Sterilization

[00840996192996]

Moist Heat or Steam Sterilization

[00840996192996]

Moist Heat or Steam Sterilization

[00840996192996]

Moist Heat or Steam Sterilization

[00840996192996]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-28
• Device Publish Date: 2023-04-20

On-Brand Devices [LANCER & THUNDERBOLT PEDICLE SCREW SYSTEM]

• 00840996193016: TBOLT,C/D FULCRUM,X-TAB
• 00840996193009: TBOLT,C/D FULCRUM,X-TAB W/MTS
• 00840996192996: THUNDERBOLT,C/D FULCRUM
• 00840996192989: THUNDERBOLT,DISTRACTOR
• 00840996192972: THUNDERBOLT,COMPRESSOR