Pro Lift 2019-0080

GUDID 00190837091033

Life Spine, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: 00190837091033
• NIH Device Record Key: a2c54976-009e-4d94-928f-19d76f75a8e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pro Lift
• Version Model Number: 2019-0080
• Catalog Number: 2019-0080
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190837091033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190488

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00190837091033]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-11-07

On-Brand Devices [Pro Lift]

• 00190837021610: 58-1228-0708P
• 00190837021535: 58-1228-0710P
• 00190837021504: 58-1228-0813P
• 00190837030940: 151-261
• 00190837091033: 2019-0080
• 00190837091026: 129-1018
• 00190837091019: 129-1017