VANGUARD 5-IN-1 TRIAL BEARING 32-483626

GUDID 00880304611856

Biomet Orthopedics, LLC

Knee tibia prosthesis trial
Primary Device ID00880304611856
NIH Device Record Keyc9ff8bad-edf6-403f-9ed2-623a6eb016ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameVANGUARD 5-IN-1 TRIAL BEARING
Version Model Number32-483626
Catalog Number32-483626
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 Usefalse
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
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
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 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 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
GS100880304611856 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


[00880304611856]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-07
Device Publish Date2016-10-21

On-Brand Devices [VANGUARD 5-IN-1 TRIAL BEARING]

0088030461205132-483690
0088030461204432-483688
0088030461203732-483686
0088030461202032-483684
0088030461201332-483682
0088030461200632-483674
0088030461199332-483670
0088030461198632-483668
0088030461197932-483666
0088030461196232-483662
0088030461195532-483654
0088030461194832-483652
0088030461193132-483650
0088030461192432-483648
0088030461191732-483646
0088030461190032-483644
0088030461189432-483634
0088030461188732-483632
0088030461187032-483630
0088030461186332-483628
0088030461185632-483626
0088030461184932-483624
0088030461183232-483622
0088030461182532-483614
0088030461181832-483612
0088030461180132-483610
0088030461179532-483608
0088030461178832-483606
0088030453550332-483660
0088030453549732-483620
0088030452093632-483602
0088030452092932-483600
0088030452091232-483604
0088030451049432-483640
0088030447597732-483664
0088030443751732-483642

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.