X FIX 09585

GUDID 00887868084430

Biomet Orthopedics, LLC

External orthopaedic fixation system, single-use, non-sterile
Primary Device ID00887868084430
NIH Device Record Key526fcb2c-536c-4e57-b446-c55c5ecf9eaf
Commercial Distribution StatusIn Commercial Distribution
Brand NameX FIX
Version Model Number09585
Catalog Number09585
Company DUNS129278169
Company NameBiomet Orthopedics, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100887868084430 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00887868084430]

Moist Heat or Steam Sterilization


[00887868084430]

Moist Heat or Steam Sterilization


[00887868084430]

Moist Heat or Steam Sterilization


[00887868084430]

Moist Heat or Steam Sterilization


[00887868084430]

Moist Heat or Steam Sterilization


[00887868084430]

Moist Heat or Steam Sterilization


[00887868084430]

Moist Heat or Steam Sterilization


[00887868084430]

Moist Heat or Steam Sterilization


[00887868084430]

Moist Heat or Steam Sterilization


[00887868084430]

Moist Heat or Steam Sterilization


[00887868084430]

Moist Heat or Steam Sterilization


[00887868084430]

Moist Heat or Steam Sterilization


[00887868084430]

Moist Heat or Steam Sterilization


[00887868084430]

Moist Heat or Steam Sterilization


[00887868084430]

Moist Heat or Steam Sterilization


[00887868084430]

Moist Heat or Steam Sterilization


[00887868084430]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-28

On-Brand Devices [X FIX]

0088786808175003065
0088848010525103165
0088786808443009585
0088786808442309580
0088786808355606187
0088786808353206182
0088786808351806177
0088786808328005060
0088786808204703190
0088848011145006172
0088848010923505070
0088848010553403200
0088848010545903191
0088848010539803187
0088848010527503170
0088848010512103148
0088848010511403145
0088848010505303135
0088848010495703120
0088786808997813180
0088786808434807130
0088786808433107129
0088786808432407128
0088786808431707125
0088786808430007120
0088786808425607100
0088786808362406258
0088786808331005125
0088786808330305080
0088786808327305045
0088786808326605040
0088786808324205030
0088786808323505025
0088786808322805021
0088786808321105020
0088786808260304490
0088786808258004480
0088786808212203235
0088786808200903180
0088786808192703160
0088786808188003155
0088786808185903111
0088786808182803100
0088786808181103095
0088786808180403090
0088786808179803085
0088786808178103080
0088786808177403075
0088786808176703070
0088786808174303060

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