INFINITY

GUDID 00840420122445

WRIGHT MEDICAL TECHNOLOGY, INC.

Mobile-bearing total ankle prosthesis
Primary Device ID00840420122445
NIH Device Record Key7a47a94b-91b6-4efc-8de5-059253ff4e1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameINFINITY
Version Model Number33636606
Company DUNS807201207
Company NameWRIGHT MEDICAL TECHNOLOGY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com

Device Dimensions

Height6 Millimeter
Device Size Text, specify0
Height6 Millimeter
Device Size Text, specify0
Height6 Millimeter
Device Size Text, specify0
Height6 Millimeter
Device Size Text, specify0
Height6 Millimeter
Device Size Text, specify0
Height6 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840420122445 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSNPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

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 Date2015-10-01

On-Brand Devices [INFINITY]

0088979700647733620136
0088979700646033620135
0088979700645333620134
0088979700644633620133
0088979700643933620132
0088979700486233600191
0088979700485533600190
0088979700479433600170
0088979700464033600136
0088979700463333600135
0088979700462633600134
0088979700461933600133
0088979700460233600132
0088979700621733609034
0088979700484833600176
0088979700483133600175
0088979700482433600174
0088979700481733600173
0088979700480033600172
0088979700478733600166
0088979700477033600165
0088979700476333600164
0088979700475633600163
0088979700474933600162
0088979700473233600161
0088979700397133600025
0084042012297133656612
0084042012296433656610
0084042012295733656608
0084042012294033656606
0084042012293333656513
0084042012292633656511
0084042012291933656509
0084042012290233656507
0084042012289633655512
0084042012288933655510
0084042012287233655508
0084042012286533655506
0084042012285833655413
0084042012284133655411
0084042012283433655409
0084042012282733655407
0084042012281033654412
0084042012280333654410
0084042012279733654408
0084042012278033654406
0084042012277333654313
0084042012276633654311
0084042012275933654309
0084042012274233654307

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