AUDERE POSTERIOR LUMBAR SPACER SYSTEM 30290111

GUDID 00819824020640

THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AUDERE LUMBAR SPACER SYSTEM MAY BE IMPLANTED BILATERALLY USING A POSTERIOR (PLIF) APPROACH, OR A SINGLE DEVICE EMPLOYING A TRANSFORAMINAL (TLIF) APPROACH.

MET 1 TECHNOLOGIES, LLC

Ceramic spinal interbody fusion cage
Primary Device ID00819824020640
NIH Device Record Key48246493-00fd-4750-bf0c-a29fb0d4af44
Commercial Distribution StatusIn Commercial Distribution
Brand NameAUDERE POSTERIOR LUMBAR SPACER SYSTEM
Version Model Number30290111
Catalog Number30290111
Company DUNS080474650
Company NameMET 1 TECHNOLOGIES, LLC
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

Customer Support Contacts

Phone9154726762
Emailyone@ldmedicalprods.com
Phone9154726762
Emailyone@ldmedicalprods.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100819824020640 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00819824020640]

Moist Heat or Steam Sterilization


[00819824020640]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2017-09-08

On-Brand Devices [AUDERE POSTERIOR LUMBAR SPACER SYSTEM]

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00819824020879THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
00819824020862THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
00819824020855THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
00819824020848THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
00819824020831THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
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00819824020800THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
00819824020794THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
00819824020787THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
00819824020770THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
00819824020763THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
00819824020756THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
00819824020749THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
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00819824020725THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
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00819824020701THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
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00819824020688THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
00819824020671THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
00819824020664THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
00819824020657THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
00819824020640THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
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00819824020626THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
00819824020619THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
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00819824020596THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
00819824020589THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
00819824020572THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
00819824020565THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
00819824020558THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
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00819824020510THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AU
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00857215007153THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS AND INSTRUMENTS. THE AUD
00857215007146THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS AND INSTRUMENTS. THE AUD
00857215007139THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS AND INSTRUMENTS. THE AUD
00857215007122THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS AND INSTRUMENTS. THE AUD
00857215007115The AUDERE Posterior Lumbar Spacer System consists of implants, trials and instruments. The AUD
00857215007108The AUDERE Posterior Lumbar Spacer System consists of implants, trials and instruments. The AUD
00857215007092THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS AND INSTRUMENTS. THE AUD
00857215007085The AUDERE Posterior Lumbar Spacer System consists of implants, trials and instruments. The AUDE

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