ProLift Lateral Helo

GUDID 00190837138462

Life Spine, Inc.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00190837138462
• NIH Device Record Key: 89b33801-5489-4626-b35a-29908700488a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProLift Lateral Helo
• Version Model Number: 69-1850-0816LP
• 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	00190837138462 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210061

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

Radiation Sterilization

[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

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[00190837138462]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-08
• Device Publish Date: 2022-01-31

Devices Manufactured by Life Spine, Inc.

• 00190837169428 - TruLift 1-Hole Plate: 2024-03-28
• 00190837147327 - ProLift Lateral: 2024-03-21
• 00190837171674 - ProLift Lateral: 2024-03-21
• 00190837138974 - ProLift: 2024-02-08
• 00190837169411 - TruLift: 2024-02-02
• 00190837116248 - Aileron: 2023-11-16
• 00190837168322 - ARx: 2023-11-16
• 00190837135393 - ARx: 2023-10-16