ProLift Expandable Spacer

GUDID 00190837021665

Life Spine, Inc.

Metallic spinal fusion cage, non-sterile

• Primary Device ID: 00190837021665
• NIH Device Record Key: b578e91d-c446-4297-971d-2640bbba3ff2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProLift Expandable Spacer
• Version Model Number: 58-1228-1510D
• 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	00190837021665 [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]

• 00190837021665: 58-1228-1510D
• 00190837021658: 58-1228-1508P
• 00190837021641: 58-1228-1508D
• 00190837021634: 58-1228-1210D
• 00190837021627: 58-1228-1208P