Affixus® 814550075

GUDID 00887868568251

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID00887868568251
NIH Device Record Key58b54edd-77a3-4b29-99c0-7cb3884a3ddc
Commercial Distribution StatusIn Commercial Distribution
Brand NameAffixus®
Version Model Number8145-50-075
Catalog Number814550075
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
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS100887868568251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-06
Device Publish Date2023-05-29

On-Brand Devices [Affixus®]

008878685682688145-50-080
008878685682518145-50-075
008878685682448145-50-070
008878685682378145-50-065
008878685682208145-50-060
008878685682138145-50-058
008878685682068145-50-056
008878685681908145-50-054
008878685681838145-50-052
008878685681768145-50-050
008878685681698145-50-048
008878685681528145-50-046
008878685681458145-50-044
008878685670708145-50-042
008878685670638145-50-040
008878685670568145-50-038
008878685670498145-50-036
008878685670328145-50-034
008878685670258145-50-032
008878685670188145-50-030
008878685670018145-50-028
008878685669988145-50-026
008878685669818145-50-024
008878685669748145-50-022
008878685669678145-50-020
008878685701482112-01-320
008878685700252112-01-209
008878685708962112-01-208
008878685708892112-01-207

Trademark Results [Affixus]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AFFIXUS
AFFIXUS
77944955 3912289 Live/Registered
BIOMET C.V.
2010-02-25

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