Elatus Lumbar Plate System 5015-1830S

GUDID 00840273321354

Lumbar Plate 2 Hole 30mm

Aegis 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

• Primary Device ID: 00840273321354
• NIH Device Record Key: 17dd6f20-7d30-4b32-b5e3-6439ae3e5d79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elatus Lumbar Plate System
• Version Model Number: 5015-1830S
• Catalog Number: 5015-1830S
• 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	00840273321354 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223719

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-18
• Device Publish Date: 2023-01-30

On-Brand Devices [Elatus Lumbar Plate System]

• 00840273321354: Lumbar Plate 2 Hole 30mm
• 00840273321347: Lumbar Plate 2 Hole 28mm
• 00840273321330: Lumbar Plate 2 Hole 27mm
• 00840273321323: Lumbar Plate 2 Hole 26mm
• 00840273321002: Lumbar Plate 2 Hole 30mm
• 00840273320999: Lumbar Plate 2 Hole 28mm
• 00840273320982: Lumbar Plate 2 Hole 27mm
• 00840273320975: Lumbar Plate 2 Hole 26mm