X FIX DYNAFIX SYSTEM 13130

GUDID 00880304529199

Biomet Orthopedics, LLC

External orthopaedic fixation system, single-use, non-sterile
Primary Device ID00880304529199
NIH Device Record Key38ec476f-85a7-4417-a1b3-b6afe2c1553c
Commercial Distribution StatusIn Commercial Distribution
Brand NameX FIX DYNAFIX SYSTEM
Version Model Number13130
Catalog Number13130
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 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
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 Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304529199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304529199]

Moist Heat or Steam Sterilization


[00880304529199]

Moist Heat or Steam Sterilization


[00880304529199]

Moist Heat or Steam Sterilization


[00880304529199]

Moist Heat or Steam Sterilization


[00880304529199]

Moist Heat or Steam Sterilization


[00880304529199]

Moist Heat or Steam Sterilization


[00880304529199]

Moist Heat or Steam Sterilization


[00880304529199]

Moist Heat or Steam Sterilization


[00880304529199]

Moist Heat or Steam Sterilization


[00880304529199]

Moist Heat or Steam Sterilization


[00880304529199]

Moist Heat or Steam Sterilization


[00880304529199]

Moist Heat or Steam Sterilization


[00880304529199]

Moist Heat or Steam Sterilization


[00880304529199]

Moist Heat or Steam Sterilization


[00880304529199]

Moist Heat or Steam Sterilization


[00880304529199]

Moist Heat or Steam Sterilization


[00880304529199]

Moist Heat or Steam Sterilization


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 [X FIX DYNAFIX SYSTEM]

0088030452926713120
0088030452919913130
0088030450998613150
0088030450600813155
0088030450516213125
0088030449176213135
0088030449165613165

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