HARRIER Choice Spine Intervertebral Body Device

GUDID 00840996157308

HARRIER,SHORT INSERTER SHAFT

Choice Spine, LP

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840996157308
• NIH Device Record Key: 655922ff-ea59-448c-82a7-a83874e38c15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HARRIER Choice Spine Intervertebral Body Device
• Version Model Number: J070-0045
• 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	00840996157308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162103

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[00840996157308]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-06-02

On-Brand Devices [HARRIER Choice Spine Intervertebral Body Device]

• 00840996157315: HARRIER,SHORT ANT-LAT INSERTER SHEATH
• 00840996157308: HARRIER,SHORT INSERTER SHAFT
• 00840996150125: HARRIER,DISTRACTOR INSERTER