ProLift Expandable Spacer System Post Pack

GUDID 00190837021580

Life Spine, Inc.

Metallic spinal fusion cage, non-sterile

• Primary Device ID: 00190837021580
• NIH Device Record Key: b8aa255d-ef68-4ae9-a1d0-573063a5b18b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProLift Expandable Spacer System Post Pack
• Version Model Number: 58-1228-0710D
• Company DUNS: 183641617
• Company Name: Life Spine, Inc.
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190837021580 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173182

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: 2018-12-17
• Device Publish Date: 2018-11-14

On-Brand Devices [ProLift Expandable Spacer System Post Pack]

• 00190837022747: 58-1228-1016D
• 00190837022730: 58-1228-0813D
• 00190837021603: 58-1228-1016P
• 00190837021597: 58-1228-1208D
• 00190837021580: 58-1228-0710D
• 00190837021573: 58-1228-0708D