VANGUARD SSK 360 KNEE SYSTEM 185146

GUDID 00880304481275

Biomet Orthopedics, LLC

Tibial insert
Primary Device ID00880304481275
NIH Device Record Key6031fb90-04d1-4246-abb7-009ee110a0a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameVANGUARD SSK 360 KNEE SYSTEM
Version Model Number185146
Catalog Number185146
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

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304481275 [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 [VANGUARD SSK 360 KNEE SYSTEM]

00880304481398185174
00880304481381185172
00880304481374185170
00880304481367185168
00880304481350185166
00880304481343185164
00880304481336185162
00880304481329185160
00880304481312185154
00880304481305185152
00880304481299185150
00880304481282185148
00880304481275185146
00880304481268185144
00880304481251185142
00880304467408185140

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