Presidio Anterior Lumbar Fixation System 125-612

GUDID 00190837043339

Wedge Distractor, 8mm x 12mm

Life Spine, Inc.

Spinal fixation plate, non-bioabsorbable
Primary Device ID00190837043339
NIH Device Record Keyfd9c261e-812d-49c6-aeab-875589d30e3c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePresidio Anterior Lumbar Fixation System
Version Model Number125-612
Catalog Number125-612
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
GS100190837043339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837043339]

Moist Heat or Steam Sterilization


[00190837043339]

Moist Heat or Steam Sterilization


[00190837043339]

Moist Heat or Steam Sterilization


[00190837043339]

Moist Heat or Steam Sterilization


[00190837043339]

Moist Heat or Steam Sterilization


[00190837043339]

Moist Heat or Steam Sterilization


[00190837043339]

Moist Heat or Steam Sterilization


[00190837043339]

Moist Heat or Steam Sterilization


[00190837043339]

Moist Heat or Steam Sterilization


[00190837043339]

Moist Heat or Steam Sterilization


[00190837043339]

Moist Heat or Steam Sterilization


[00190837043339]

Moist Heat or Steam Sterilization


[00190837043339]

Moist Heat or Steam Sterilization


[00190837043339]

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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