ABTross ALIF Expandable Cage System 2938-0815S

GUDID 00840273320197

ALIF 29x38x15~19mm, 8°

Aegis Spine, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: 00840273320197
• NIH Device Record Key: 49e71d6b-58dc-454d-898f-eab70f99f842
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABTross ALIF Expandable Cage System
• Version Model Number: 2938-0815S
• Catalog Number: 2938-0815S
• Company DUNS: 017993061
• Company Name: Aegis 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840273320197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221719

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-22
• Device Publish Date: 2022-11-14

On-Brand Devices [ABTross ALIF Expandable Cage System]

• 00840273320029: ALIF 24x32x9~13mm, 15°
• 00840273320012: ALIF 24x32x6~10mm, 15°
• 00840273320005: ALIF 24x32x15~19mm, 12°
• 00840273319993: ALIF 24x32x12~16mm, 12°
• 00840273319986: ALIF 24x32x9~13mm, 12°
• 00840273319979: ALIF 24x32x15~19mm, 8°
• 00840273319962: ALIF 24x32x12~16mm, 8°
• 00840273319955: ALIF 24x32x9~13mm, 8°
• 00840273320388: ALIF 29x38x15~19mm, 30°
• 00840273320371: ALIF 29x38x12~16mm, 30°
• 00840273320364: ALIF 29x38x9~13mm, 30°
• 00840273320357: ALIF 29x38x6~10mm, 30°
• 00840273320340: ALIF 29x38x15~19mm, 25°
• 00840273320333: ALIF 29x38x12~16mm, 25°
• 00840273320326: ALIF 29x38x9~13mm, 25°
• 00840273320319: ALIF 29x38x6~10mm, 25°
• 00840273320302: ALIF 29x38x15~19mm, 20°
• 00840273320296: ALIF 29x38x12~16mm, 20°
• 00840273320289: ALIF 29x38x9~13mm, 20°
• 00840273320272: ALIF 29x38x6~10mm, 20°
• 00840273320265: ALIF 29x38x15~19mm, 15°
• 00840273320258: ALIF 29x38x12~16mm, 15°
• 00840273320241: ALIF 29x38x9~13mm, 15°
• 00840273320234: ALIF 29x38x6~10mm, 15°
• 00840273320227: ALIF 29x38x15~19mm, 12°
• 00840273320210: ALIF 29x38x12~16mm, 12°
• 00840273320203: ALIF 29x38x9~13mm, 12°
• 00840273320197: ALIF 29x38x15~19mm, 8°
• 00840273320180: ALIF 29x38x12~16mm, 8°
• 00840273320173: ALIF 29x38x9~13mm, 8°
• 00840273320166: ALIF 24x32x15~19mm, 30°
• 00840273320159: ALIF 24x32x12~16mm, 30°
• 00840273320142: ALIF 24x32x9~13mm, 30°
• 00840273320135: ALIF 24x32x6~10mm, 30°
• 00840273320128: ALIF 24x32x15~19mm, 25°
• 00840273320111: ALIF 24x32x12~16mm, 25°
• 00840273320104: ALIF 24x32x9~13mm, 25°
• 00840273320098: ALIF 24x32x6~10mm, 25°
• 00840273320081: ALIF 24x32x15~19mm, 20°
• 00840273320074: ALIF 24x32x12~16mm, 20°
• 00840273320067: ALIF 24x32x9~13mm, 20°
• 00840273320050: ALIF 24x32x6~10mm, 20°
• 00840273320043: ALIF 24x32x15~19mm, 15°
• 00840273320036: ALIF 24x32x12~16mm, 15°