XS Multi-Axial Correction System 14-415360

GUDID 00880304591905

Biomet Orthopedics, LLC

External orthopaedic fixation system, single-use, non-sterile
Primary Device ID00880304591905
NIH Device Record Keyc6573d58-e711-4b19-b87b-44e46599fb36
Commercial Distribution StatusIn Commercial Distribution
Brand NameXS Multi-Axial Correction System
Version Model Number14-415360
Catalog Number14-415360
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
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
GS100880304591905 [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

[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


[00880304591905]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-11
Device Publish Date2020-08-03

On-Brand Devices [XS Multi-Axial Correction System]

0088030453465015265
0088030453377615280
0088030453376915244
0088030453242715285
0088848019050915295
0088848019044815275
0088848019034915245
0088848019031815230
0088848015322113115
0088848015321413110
0088848015320713105
0088030459190514-415360

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