TriMed Humeral Supracondylar Fixation System

Plate, Fixation, Bone

TriMed, Inc.

The following data is part of a premarket notification filed by Trimed, Inc. with the FDA for Trimed Humeral Supracondylar Fixation System.

Pre-market Notification Details

Device IDK151735
510k NumberK151735
Device Name:TriMed Humeral Supracondylar Fixation System
ClassificationPlate, Fixation, Bone
Applicant TriMed, Inc. 27533 Avenue Hopkins Santa Clarita,  CA  91355
ContactMichael Capellan
CorrespondentMichael Capellan
TriMed, Inc. 27533 Avenue Hopkins Santa Clarita,  CA  91355
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-26
Decision Date2016-01-29
Summary:summary

NIH GUDID Devices

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