TORNIER, PITON FIXATION IMPLANT SYSTEM

Fastener, Fixation, Nondegradable, Soft Tissue

TORNIER

The following data is part of a premarket notification filed by Tornier with the FDA for Tornier, Piton Fixation Implant System.

Pre-market Notification Details

Device IDK091870
510k NumberK091870
Device Name:TORNIER, PITON FIXATION IMPLANT SYSTEM
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant TORNIER 100 CUMMINGS CENTER SUITE 444C Beverly,  MA  01915
ContactHoward L Schrayer
CorrespondentHoward L Schrayer
TORNIER 100 CUMMINGS CENTER SUITE 444C Beverly,  MA  01915
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-23
Decision Date2009-09-21
Summary:summary

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