MAK OSS FEMORAL BUMPER TRIAL CP461011

GUDID 00880304658363

Biomet Orthopedics, LLC

Knee femur prosthesis trial Knee femur prosthesis trial Knee femur prosthesis trial Knee femur prosthesis trial Knee femur prosthesis trial Knee femur prosthesis trial Knee femur prosthesis trial Knee femur prosthesis trial Knee femur prosthesis trial Knee femur prosthesis trial Knee femur prosthesis trial Knee femur prosthesis trial Knee femur prosthesis trial Knee femur prosthesis trial
Primary Device ID00880304658363
NIH Device Record Key340346ab-dad3-43e3-8f14-40ed2d8dbe7d
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAK OSS FEMORAL BUMPER TRIAL
Version Model NumberCP461011
Catalog NumberCP461011
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 Identifiers

Device Issuing AgencyDevice ID
GS100880304658363 [Primary]
GS100880304658363 [Primary]
GS100880304658363 [Primary]
GS100880304658363 [Primary]
GS100880304658363 [Primary]
GS100880304658363 [Primary]
GS100880304658363 [Primary]
GS100880304658363 [Primary]
GS100880304658363 [Primary]
GS100880304658363 [Primary]
GS100880304658363 [Primary]
GS100880304658363 [Primary]
GS100880304658363 [Primary]
GS100880304658363 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304658363]

Moist Heat or Steam Sterilization


[00880304658363]

Moist Heat or Steam Sterilization


[00880304658363]

Moist Heat or Steam Sterilization


[00880304658363]

Moist Heat or Steam Sterilization


[00880304658363]

Moist Heat or Steam Sterilization


[00880304658363]

Moist Heat or Steam Sterilization


[00880304658363]

Moist Heat or Steam Sterilization


[00880304658363]

Moist Heat or Steam Sterilization


[00880304658363]

Moist Heat or Steam Sterilization


[00880304658363]

Moist Heat or Steam Sterilization


[00880304658363]

Moist Heat or Steam Sterilization


[00880304658363]

Moist Heat or Steam Sterilization


[00880304658363]

Moist Heat or Steam Sterilization


[00880304658363]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-30
Device Publish Date2020-07-22

On-Brand Devices [MAK OSS FEMORAL BUMPER TRIAL]

00880304658370CP461012
00880304658363CP461011

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.