AGC V2 HPS TOTAL KNEE SYSTEM RD180011

GUDID 00880304149779

Biomet Orthopedics, LLC

Uncoated knee femur prosthesis, metallic
Primary Device ID00880304149779
NIH Device Record Key588da42e-4e5f-406d-8778-ef9594250af2
Commercial Distribution StatusIn Commercial Distribution
Brand NameAGC V2 HPS TOTAL KNEE SYSTEM
Version Model NumberRD180011
Catalog NumberRD180011
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

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304149779 [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 Number4
Public Version Date2019-12-11
Device Publish Date2015-10-24

On-Brand Devices [AGC V2 HPS TOTAL KNEE SYSTEM]

00880304149809RD180014
00880304149793RD180013
00880304149786RD180012
00880304149779RD180011
00880304149762RD180010

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