ASCENT KNEE SYSTEM 179860

GUDID 00880304265547

Biomet Orthopedics, LLC

Tibial insert
Primary Device ID00880304265547
NIH Device Record Key3b219fa5-e4ac-468d-9fda-f9b78dda2ba2
Commercial Distribution StatusIn Commercial Distribution
Brand NameASCENT KNEE SYSTEM
Version Model Number179860
Catalog Number179860
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

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 Identifiers

Device Issuing AgencyDevice ID
GS100880304265547 [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 [ASCENT KNEE SYSTEM]

00880304265592179865
00880304265585179864
00880304265578179863
00880304265561179862
00880304265554179861
00880304265547179860
00880304265530179855
00880304265523179854
00880304265516179853
00880304265509179852
00880304265493179851
00880304265486179850
00880304265479179845
00880304265462179844
00880304265455179843
00880304265448179842
00880304265431179841
00880304265424179840
00880304265417179835
00880304265400179834
00880304265394179833
00880304265387179832
00880304265370179831
00880304265356179830
00880304265349179825
00880304265332179824
00880304265325179823
00880304265318179822
00880304265301179821
00880304265295179820
00880304265288179815
00880304265271179814
00880304265264179813
00880304265257179812
00880304265240179811
00880304265233179810
00880304264687179416
00880304264670179415
00880304264663179414
00880304264649179413
00880304264632179412
00880304264625179411
00880304264618179406
00880304264601179405
00880304264595179404
00880304264588179403
00880304264571179402
00880304264557179401
00880304264540179395
00880304264533179394

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