INBONE ( I AND II) TOTAL ANKLE SYSTEMS

Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer

WRIGHT MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Inbone ( I And Ii) Total Ankle Systems.

Pre-market Notification Details

Device IDK123059
510k NumberK123059
Device Name:INBONE ( I AND II) TOTAL ANKLE SYSTEMS
ClassificationProsthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Applicant WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
ContactRyan Bormann
CorrespondentRyan Bormann
WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
Product CodeHSN  
CFR Regulation Number888.3110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-01
Decision Date2013-03-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840420124876 K123059 000
00840420124739 K123059 000
00840420124746 K123059 000
00840420124753 K123059 000
00840420124760 K123059 000
00840420124777 K123059 000
00840420124784 K123059 000
00840420124791 K123059 000
00840420124807 K123059 000
00840420124814 K123059 000
00840420124821 K123059 000
00840420124838 K123059 000
00840420124845 K123059 000
00840420124852 K123059 000
00840420124869 K123059 000
00840420124722 K123059 000

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