ProAM ALIF System LN-033425-0614

GUDID 00810152900024

Fixated ALIF 3-Hole - 34mm x 25mm x 14mm, 6°

Pro Surgical, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: 00810152900024
• NIH Device Record Key: 5e6a47cd-083e-4344-bb24-4a606a38b521
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProAM ALIF System
• Version Model Number: LN-033425-0614
• Catalog Number: LN-033425-0614
• Company DUNS: 119149675
• Company Name: Pro Surgical, Inc.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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	00810152900024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240126

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

[00810152900024]

Moist Heat or Steam Sterilization

[00810152900024]

Moist Heat or Steam Sterilization

[00810152900024]

Moist Heat or Steam Sterilization

[00810152900024]

Moist Heat or Steam Sterilization

[00810152900024]

Moist Heat or Steam Sterilization

[00810152900024]

Moist Heat or Steam Sterilization

[00810152900024]

Moist Heat or Steam Sterilization

[00810152900024]

Moist Heat or Steam Sterilization

[00810152900024]

Moist Heat or Steam Sterilization

[00810152900024]

Moist Heat or Steam Sterilization

[00810152900024]

Moist Heat or Steam Sterilization

[00810152900024]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-20
• Device Publish Date: 2024-12-12

On-Brand Devices [ProAM ALIF System]

• 00810152900017: Fixated ALIF 3-Hole - 34mm x 25mm x 12mm, 6°
• 00810152900000: Fixated ALIF 3-Hole - 34mm x 25mm x 10mm, 6°
• 00810152900024: Fixated ALIF 3-Hole - 34mm x 25mm x 14mm, 6°