TruLift

GUDID 00190837097349

Life Spine, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: 00190837097349
• NIH Device Record Key: 711cb7e3-70a8-427b-a1a8-df50744af14a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruLift
• Version Model Number: 68-1028-1510
• 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	00190837097349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201721

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00190837097349]

Radiation Sterilization

[00190837097349]

Radiation Sterilization

[00190837097349]

Radiation Sterilization

[00190837097349]

Radiation Sterilization

[00190837097349]

Radiation Sterilization

[00190837097349]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-14
• Device Publish Date: 2022-06-06

On-Brand Devices [TruLift]

• 00190837097271: 68-1028-0708
• 00190837097288: 68-1028-0710
• 00190837097318: 68-1028-1208
• 00190837097349: 68-1028-1510
• 00190837097332: 68-1028-1508
• 00190837097295: 68-1028-0813
• 00190837097325: 68-1028-1210
• 00190837097301: 68-1028-1016
• 00190837169411: 182-100