OXFORD FIXED LATERAL 32-423003

GUDID 00880304676114

Biomet Orthopedics, LLC

Knee femur prosthesis trial Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable
Primary Device ID00880304676114
NIH Device Record Keyfd179507-04ab-4fe7-b846-cd784e39783f
Commercial Distribution StatusIn Commercial Distribution
Brand NameOXFORD FIXED LATERAL
Version Model Number32-423003
Catalog Number32-423003
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

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 Identifiers

Device Issuing AgencyDevice ID
GS100880304676114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304676114]

Moist Heat or Steam Sterilization


[00880304676114]

Moist Heat or Steam Sterilization


[00880304676114]

Moist Heat or Steam Sterilization


[00880304676114]

Moist Heat or Steam Sterilization


[00880304676114]

Moist Heat or Steam Sterilization


[00880304676114]

Moist Heat or Steam Sterilization


[00880304676114]

Moist Heat or Steam Sterilization


[00880304676114]

Moist Heat or Steam Sterilization


[00880304676114]

Moist Heat or Steam Sterilization


[00880304676114]

Moist Heat or Steam Sterilization


[00880304676114]

Moist Heat or Steam Sterilization


[00880304676114]

Moist Heat or Steam Sterilization


[00880304676114]

Moist Heat or Steam Sterilization


[00880304676114]

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 [OXFORD FIXED LATERAL]

0088030467687932-423394
0088030467668832-423391
0088030467667132-423390
0088030467666432-423389
0088030467665732-423388
0088030467664032-423387
0088030467663332-423386
0088030467662632-423385
0088030467661932-423384
0088030467660232-423383
0088030467659632-423382
0088030467658932-423381
0088030467657232-423380
0088030467656532-423379
0088030467655832-423378
0088030467654132-423377
0088030467653432-423376
0088030467652732-423375
0088030467651032-423374
0088030467650332-423373
0088030467649732-423372
0088030467648032-423371
0088030467647332-423370
0088030467646632-423369
0088030467645932-423368
0088030467644232-423367
0088030467643532-423366
0088030467642832-423365
0088030467641132-423364
0088030467640432-423363
0088030467639832-423362
0088030467638132-423030
0088030467637432-423029
0088030467636732-423028
0088030467635032-423027
0088030467634332-423026
0088030467633632-423025
0088030467632932-423024
0088030467631232-423023
0088030467630532-423022
0088030467629932-423021
0088030467628232-423020
0088030467627532-423019
0088030467626832-423018
0088030467625132-423017
0088030467624432-423016
0088030467623732-423015
0088030467622032-423014
0088030467621332-423013
0088030467620632-423012

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