Elatus Lumbar Plate System 5015-1830S

GUDID 00840273321354

Lumbar Plate 2 Hole 30mm

Aegis Spine, Inc.

Spinal fixation plate, non-bioabsorbable
Primary Device ID00840273321354
NIH Device Record Key17dd6f20-7d30-4b32-b5e3-6439ae3e5d79
Commercial Distribution StatusIn Commercial Distribution
Brand NameElatus Lumbar Plate System
Version Model Number5015-1830S
Catalog Number5015-1830S
Company DUNS017993061
Company NameAegis Spine, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840273321354 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-18
Device Publish Date2023-01-30

On-Brand Devices [Elatus Lumbar Plate System]

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

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