TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR

Fastener, Fixation, Nondegradable, Soft Tissue

TORNIER, INC.

The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Tornier Insite(tm) Ft Peek Knotless Suture Anchor.

Pre-market Notification Details

Device IDK133777
510k NumberK133777
Device Name:TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant TORNIER, INC. 10801 Nesbitt Avenue South Bloomington,  MN  55437
ContactMireille Lemery
CorrespondentMireille Lemery
TORNIER, INC. 10801 Nesbitt Avenue South Bloomington,  MN  55437
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-12
Decision Date2014-04-04
Summary:summary

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