AGC TRADITION KNEE SYSTEM 151085

GUDID 00880304241015

Biomet Orthopedics, LLC

Uncoated knee tibia prosthesis, metallic
Primary Device ID00880304241015
NIH Device Record Keyf46227aa-9a1c-444e-bcea-2af61058b092
Commercial Distribution StatusIn Commercial Distribution
Brand NameAGC TRADITION KNEE SYSTEM
Version Model Number151085
Catalog Number151085
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 Datefalse
Expiration Datetrue
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

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304241015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2015-10-24

On-Brand Devices [AGC TRADITION KNEE SYSTEM]

00880304241374151164
00880304241367151162
00880304241350151160
00880304241343151158
00880304241336151156
00880304241329151154
00880304241312151152
00880304241305151150
00880304241299151148
00880304241282151146
00880304241275151144
00880304241268151142
00880304241251151140
00880304241220151134
00880304241213151132
00880304241206151130
00880304241190151128
00880304241183151126
00880304241176151124
00880304241169151122
00880304241152151120
00880304241145151118
00880304241138151116
00880304241107151110
00880304241053151089
00880304241046151088
00880304241039151087
00880304241022151086
00880304241015151085
00880304241008151084
00880304240995151083
00880304240988151082
00880304240971151081
00880304240964151080
00880304240957151079
00880304240940151078
00880304240933151077
00880304240926151076
00880304240919151075
00880304240902151074
00880304240896151073
00880304240889151072
00880304240872151071
00880304240858151070
00880304240841151069
00880304240834151068
00880304240827151067
00880304240803151066
00880304240780151065
00880304240773151064

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