Elatus Lumbar Plate System 5015-1628

GUDID 00840273320999

Lumbar Plate 2 Hole 28mm

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	00840273320999
NIH Device Record Key	582019c7-042f-4b80-a5f2-c4b4aad9961d
Commercial Distribution Status	In Commercial Distribution
Brand Name	Elatus Lumbar Plate System
Version Model Number	5015-1628
Catalog Number	5015-1628
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	00840273320999 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K223719

FDA Product Code

KWQ	Appliance, Fixation, Spinal Intervertebral Body