Lancer Open Pedicle Screw System

GUDID 00840996174701

LANCER,POSITIONER,TULIP,T-HANDLE

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840996174701
• NIH Device Record Key: 05767fbf-9384-4130-949e-52815fca58f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lancer Open Pedicle Screw System
• Version Model Number: M070-0128
• 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	00840996174701 [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

[00840996174701]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-30
• Device Publish Date: 2018-09-29

On-Brand Devices [Lancer Open Pedicle Screw System]

• 00840996177382: Tapered Cannulated T25 Driver
• 00840996175067: LANCER,DRIVER,HEXALOBE,TAPERED
• 00840996174701: LANCER,POSITIONER,TULIP,T-HANDLE
• 00840996172936: LANCER,PEDICLE PROBE
• 00840996170307: LANCER,PROBE-TAP,1/4"COMBINATION