HARRIER-SA Lumber Interbody System

GUDID 00840996171038

HARRIER-SA,STERILE,COVERPLATE,ZERO,17

Choice Spine, LP

Intervertebral-body internal spinal fixation system

• Primary Device ID: 00840996171038
• NIH Device Record Key: a1e15399-2269-402a-b588-f4bff0c01c0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HARRIER-SA Lumber Interbody System
• Version Model Number: S-YT40-Z017
• 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: true
• Expiration Date: true
• 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	00840996171038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180519

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-20
• Device Publish Date: 2018-08-20

On-Brand Devices [HARRIER-SA Lumber Interbody System]

• 00840996171038: HARRIER-SA,STERILE,COVERPLATE,ZERO,17
• 00840996171007: HARRIER-SA,STERILE,COVERPLATE,ZERO,12