CALCANEAL FRACTURE PLATE SYSTEM

Plate, Fixation, Bone

TORNIER, INC.

The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Calcaneal Fracture Plate System.

Pre-market Notification Details

Device IDK090582
510k NumberK090582
Device Name:CALCANEAL FRACTURE PLATE SYSTEM
ClassificationPlate, Fixation, Bone
Applicant TORNIER, INC. 100 CUMMINGS CENTER SUITE 444C Beverly,  MA  01915
ContactBrahim Hadri
CorrespondentBrahim Hadri
TORNIER, INC. 100 CUMMINGS CENTER SUITE 444C Beverly,  MA  01915
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-03-04
Decision Date2009-07-02
Summary:summary

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