BIOMET KNEE SYSTEM 148312

GUDID 00880304529007

Biomet Orthopedics, LLC

Knee stem
Primary Device ID00880304529007
NIH Device Record Keydc1f5336-4d29-408f-8c28-970602af52ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOMET KNEE SYSTEM
Version Model Number148312
Catalog Number148312
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
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
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304529007 [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 Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [BIOMET KNEE SYSTEM]

00880304555754185188
00880304555747185187
00880304555730185186
00880304555723185185
00880304554498141567
00880304554481141566
00880304554474141565
00880304554467141564
00880304554450141563
00880304554443141562
00880304554436141561
00880304554375141336
00880304554368141333
00880304554351141330
00880304554344141311
00880304545786148324
00880304545779148283
00880304545632148290
00880304545625148294
00880304545618148292
00880304545601148298
00880304545595148288
00880304545588148286
00880304545571148296
00880304545564148309
00880304545557148327
00880304545540148338
00880304545533148344
00880304545526148342
00880304545519148346
00880304545502148340
00880304545496148301
00880304545489148331
00880304545472148335
00880304545465148311
00880304545458148303
00880304545441148320
00880304545434148322
00880304545427148307
00880304545410148316
00880304545403148333
00880304545397148305
00880304545380148329
00880304545373148313
00880304545366148318
00880304534674148006
00880304534667148022
00880304530577148334
00880304530560148284
00880304530553148328

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