INFINITY

GUDID 00840420122001

WRIGHT MEDICAL TECHNOLOGY, INC.

Mobile-bearing total ankle prosthesis
Primary Device ID00840420122001
NIH Device Record Key55463833-e9fb-4a70-869a-89771267f83c
Commercial Distribution Discontinuation2016-03-07
Commercial Distribution StatusNot in Commercial Distribution
Brand NameINFINITY
Version Model Number33630014
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

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100840420122001 [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]

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0088979700646033620135
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0088979700644633620133
0088979700643933620132
0088979700486233600191
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0088979700463333600135
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0088979700621733609034
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0088979700473233600161
0088979700397133600025
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0084042012276633654311
0084042012275933654309
0084042012274233654307

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