Lateral

GUDID B014ILC95022

EMINENT SPINE LLC

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage

• Primary Device ID: B014ILC95022
• NIH Device Record Key: 2de25345-0480-4f7d-ab2b-191968c006e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lateral
• Version Model Number: ILC95022
• Company DUNS: 022576742
• Company Name: EMINENT SPINE LLC
• 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: 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
HIBCC	B014ILC95022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090064

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[B014ILC95022]

Moist Heat or Steam Sterilization

[B014ILC95022]

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: 2017-02-21

On-Brand Devices [Lateral]

• B014ILC96022: ILC96022
• B014ILC96018: ILC96018
• B014ILC95522: ILC95522
• B014ILC95518: ILC95518
• B014ILC95022: ILC95022
• B014ILC95018: ILC95018
• B014ILC94522: ILC94522
• B014ILC94518: ILC94518
• B014ILC176022: ILC176022
• B014ILC176018: ILC176018
• B014ILC175522: ILC175522
• B014ILC175518: ILC175518
• B014ILC175022: ILC175022
• B014ILC175018: ILC175018
• B014ILC174522: ILC174522
• B014ILC174518: ILC174518
• B014ILC156022: ILC156022
• B014ILC156018: ILC156018
• B014ILC155522: ILC155522
• B014ILC155518: ILC155518
• B014ILC155022: ILC155022
• B014ILC155018: ILC155018
• B014ILC154522: ILC154522
• B014ILC154518: ILC154518
• B014ILC136022: ILC136022
• B014ILC136018: ILC136018
• B014ILC135522: ILC135522
• B014ILC135518: ILC135518
• B014ILC135022: ILC135022
• B014ILC135018: ILC135018
• B014ILC134522: ILC134522
• B014ILC134518: ILC134518
• B014ILC116022: ILC116022
• B014ILC116018: ILC116018
• B014ILC115522: ILC115522
• B014ILC115518: ILC115518
• B014ILC115022: ILC115022
• B014ILC115018: ILC115018
• B014ILC114522: ILC114522
• B014ILC114518: ILC114518