QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM

Fastener, Fixation, Nondegradable, Soft Tissue

WRIGHT MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Questus Polyester Suture Soft Tissue Anchor System.

Pre-market Notification Details

Device IDK953264
510k NumberK953264
Device Name:QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
ContactKim Tompkins
CorrespondentKim Tompkins
WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-13
Decision Date1995-10-20

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