TruLift 1-Hole Plate

GUDID 00190837169428

Life Spine, Inc.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00190837169428
• NIH Device Record Key: 2e9f4414-845a-4e60-934c-f4cd84ca47d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruLift 1-Hole Plate
• Version Model Number: 182-1-311
• 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: 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	00190837169428 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221806

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00190837169428]

Moist Heat or Steam Sterilization

[00190837169428]

Moist Heat or Steam Sterilization

[00190837169428]

Moist Heat or Steam Sterilization

[00190837169428]

Moist Heat or Steam Sterilization

[00190837169428]

Moist Heat or Steam Sterilization

[00190837169428]

Moist Heat or Steam Sterilization

[00190837169428]

Moist Heat or Steam Sterilization

[00190837169428]

Moist Heat or Steam Sterilization

[00190837169428]

Moist Heat or Steam Sterilization

[00190837169428]

Moist Heat or Steam Sterilization

[00190837169428]

Moist Heat or Steam Sterilization

[00190837169428]

Moist Heat or Steam Sterilization

[00190837169428]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-28
• Device Publish Date: 2024-03-20

Devices Manufactured by Life Spine, Inc.

• 00190837153410 - TruLift Lateral: 2024-10-25
• 00190837142209 - ProLift: 2024-10-18
• 00190837142278 - ProLift: 2024-10-18
• 00190837156077 - ProLift Wedge: 2024-10-18
• 00190837200060 - ProLift Wedge: 2024-10-18
• 00190837200558 - ARx: 2024-10-10
• 00190837156732 - ProLink Barb: 2024-09-25
• 00190837156749 - ProLink Barb: 2024-09-25