KLS Martin Thoracic Plating System

Plate, Fixation, Bone

KLS-MARTIN L.P.

The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Kls Martin Thoracic Plating System.

Pre-market Notification Details

Device IDK153482
510k NumberK153482
Device Name:KLS Martin Thoracic Plating System
ClassificationPlate, Fixation, Bone
Applicant KLS-MARTIN L.P. 11201 SAINT JOHNS INDUSTRIAL PARKWAY SOUTH Jacksonville,  FL  32246
ContactJennifer Damato
CorrespondentGary Moore
KLS-MARTIN L.P. 11201 SAINT JOHNS INDUSTRIAL PARKWAY SOUTH Jacksonville,  FL  32246
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-03
Decision Date2016-04-06
Summary:summary

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