Affiniti™

GUDID 00846832001767

TORNIER, INC.

Coated shoulder humeral stem prosthesis
Primary Device ID00846832001767
NIH Device Record Keyd32c3385-c203-41f7-9d34-ae44b7910578
Commercial Distribution StatusIn Commercial Distribution
Brand NameAffiniti™
Version Model Number0020006
Company DUNS968990812
Company NameTORNIER, INC.
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com

Device Dimensions

Length110 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter
Outer Diameter6 Millimeter
Length110 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100846832001767 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-16

On-Brand Devices [Affiniti™]

008468320021150020058
008468320021080020057
008468320020920020056
008468320020850020054
008468320020780020053
008468320020610020052
008468320020540020050
008468320020470020049
008468320020300020048
008468320020230020046
008468320020160020045
008468320020090020044
008468320019960020042
008468320019890020041
008468320019720020040
008468320019650020038
008468320019580020037
008468320019410020034
008468320019340020033
008468320019270020030
008468320019100020029
008468320019030020026
008468320018970020025
008468320018800020022
008468320018730020021
008468320018660020018
008468320018590020016
008468320018420020015
008468320018350020014
008468320018280020013
008468320018110020012
008468320018040020011
008468320017980020010
008468320017810020009
008468320017740020008
008468320017670020006

Trademark Results [Affiniti]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AFFINITI
AFFINITI
97477382 not registered Live/Pending
SuperLayer Labs Management, LLC
2022-06-27
AFFINITI
AFFINITI
97044570 not registered Live/Pending
Halyard MD Opco, LLC
2021-09-24
AFFINITI
AFFINITI
85514563 not registered Dead/Abandoned
KATZ, Steven
2012-01-11
AFFINITI
AFFINITI
85514563 not registered Dead/Abandoned
KATZ, Cecile
2012-01-11
AFFINITI
AFFINITI
81016986 1016986 Dead/Cancelled
Wilwood, Inc.
0000-00-00
AFFINITI
AFFINITI
79143766 4590914 Live/Registered
Koninklijke Philips nv
2014-01-22
AFFINITI
AFFINITI
77873733 3938734 Live/Registered
Tornier, Inc.
2009-11-16
AFFINITI
AFFINITI
77813762 not registered Dead/Abandoned
Terrazzo & Marble Supply Co. of IL
2009-08-27
AFFINITI
AFFINITI
77593592 not registered Dead/Abandoned
DATALOGIX, INC.
2008-10-15
AFFINITI
AFFINITI
77100548 not registered Dead/Abandoned
Farberware Licensing Company, LLC
2007-02-06
AFFINITI
AFFINITI
76154175 not registered Dead/Abandoned
Affiniti, Inc.
2000-10-26
AFFINITI
AFFINITI
74597990 1928253 Dead/Cancelled
CIGNA Corporation
1994-11-14

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