Presidio Anterior Lumbar Fixation System 125-378

GUDID 00190837043186

Presidio Variable Screw Caddy

Life 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 Spinal fixation plate, non-bioabsorbable
Primary Device ID00190837043186
NIH Device Record Key96d2111d-72b0-459b-a3c8-ba20265aa0d7
Commercial Distribution StatusIn Commercial Distribution
Brand NamePresidio Anterior Lumbar Fixation System
Version Model Number125-378
Catalog Number125-378
Company DUNS183641617
Company NameLife 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100190837043186 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837043186]

Moist Heat or Steam Sterilization

[00190837043186]

Moist Heat or Steam Sterilization

[00190837043186]

Moist Heat or Steam Sterilization

[00190837043186]

Moist Heat or Steam Sterilization

[00190837043186]

Moist Heat or Steam Sterilization

[00190837043186]

Moist Heat or Steam Sterilization

[00190837043186]

Moist Heat or Steam Sterilization

[00190837043186]

Moist Heat or Steam Sterilization

[00190837043186]

Moist Heat or Steam Sterilization

[00190837043186]

Moist Heat or Steam Sterilization

[00190837043186]

Moist Heat or Steam Sterilization

[00190837043186]

Moist Heat or Steam Sterilization

[00190837043186]

Moist Heat or Steam Sterilization

[00190837043186]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-15
Device Publish Date2019-11-07

On-Brand Devices [Presidio Anterior Lumbar Fixation System]

00190837013462125-655-40
00190837013455125-655-35
00190837013448125-655-30
00190837013431125-655-25
00190837013424125-655-20
00190837013417125-455-40
00190837013400125-455-35
00190837013394125-455-30
00190837013387125-455-25
00190837013370125-455-20
00190837013363125-50-46
00190837013356125-50-44
00190837013349125-50-42
00190837013332125-50-40
00190837013325125-50-38
00190837013318125-50-36
00190837013301125-50-34
00190837013295125-50-32
00190837013288125-365-40
00190837013271125-365-35
00190837013264125-365-30
00190837013257125-365-25
00190837013240125-365-20
00190837013233125-355-40
00190837013226125-355-35
00190837013219125-355-30
00190837013202125-355-25
00190837013196125-355-20
00190837013189125-188
00190837013172125-10-46
00190837013165125-10-44
00190837013158125-10-42
00190837013141125-10-40
00190837013134125-10-38
00190837013127125-10-36
00190837013110125-10-34
00190837013103125-10-32
00190837043438Torque Limiting Straight Handle, 15in/lbs, 1/4 Sq.
00190837043421Fixed Short Awl
00190837043414Fixed Awl
00190837043407Presidio Installer
00190837043391Lateral Plate
00190837043384Lock Plate Installer
00190837043377Media Drill Guide
001908370433603.5mm Hex Driver Tip
001908370433533.25mm Drill Tip
001908370433463.0mm Awl Tip
00190837043339Wedge Distractor, 8mm x 12mm
00190837043322Wedge Distractor, 8mm x 11mm
00190837043315Wedge Distractor, 8mm x 8mm
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