VANGUARD M PARTIAL KNEE SYSTEM US154736

GUDID 00880304180970

Biomet Orthopedics, LLC

Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis
Primary Device ID00880304180970
NIH Device Record Key973f5ab1-3edd-4060-a3e0-d9558dda3394
Commercial Distribution StatusIn Commercial Distribution
Brand NameVANGUARD M PARTIAL KNEE SYSTEM
Version Model NumberUS154736
Catalog NumberUS154736
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
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
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 Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304180970 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 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 [VANGUARD M PARTIAL KNEE SYSTEM]

00880304181106US154749
00880304181090US154748
00880304181083US154747
00880304181076US154746
00880304181069US154745
00880304181052US154744
00880304181045US154743
00880304181038US154742
00880304181021US154741
00880304181014US154740
00880304181007US154739
00880304180994US154738
00880304180987US154737
00880304180970US154736
00880304180963US154735
00880304180956US154734
00880304180949US154733
00880304180932US154732
00880304180925US154731
00880304180918US154730
00880304180901US154729
00880304180895US154728
00880304180888US154727
00880304180871US154726
00880304180864US154725
00880304180857US154724
00880304180840US154723
00880304180833US154722
00880304180826US154721
00880304180819US154720
00880304180802US154719
00880304180796US154718
00880304180789US154717
00880304180772US154716
00880304180765US154715
00880304180758US154714
00880304180741US154713
00880304180734US154712
00880304180727US154711
00880304180710US154710
00880304180703US154709
00880304180697US154708
00880304180680US154707
00880304180673US154706
00880304180666US154705
00880304180659US154704
00880304180642US154703
00880304180635US154702
00880304180628US154701
00880304180611US154700

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.