VALOR(R) ANKLE FUSION NAIL SYSTEM SCREW

Rod, Fixation, Intramedullary And Accessories

WRIGHT MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Valor(r) Ankle Fusion Nail System Screw.

Pre-market Notification Details

Device IDK110552
510k NumberK110552
Device Name:VALOR(R) ANKLE FUSION NAIL SYSTEM SCREW
ClassificationRod, Fixation, Intramedullary And Accessories
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 CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-02-28
Decision Date2011-03-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840420115997 K110552 000
00840420115980 K110552 000
00840420115973 K110552 000
00840420115966 K110552 000

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