Pitkar Locked Plating System

Plate, Fixation, Bone

S H Pitkar Orthotools Pvt Ltd.

The following data is part of a premarket notification filed by S H Pitkar Orthotools Pvt Ltd. with the FDA for Pitkar Locked Plating System.

Pre-market Notification Details

Device IDK192619
510k NumberK192619
Device Name:Pitkar Locked Plating System
ClassificationPlate, Fixation, Bone
Applicant S H Pitkar Orthotools Pvt Ltd. Plot No. EL 32, J Block, MIDC Bhosari Pune,  IN 411026
ContactVivek Mangalwedhekar
CorrespondentVivek Mangalwedhekar
S H Pitkar Orthotools Pvt Ltd. Plot No. EL 32, J Block, MIDC Bhosari Pune,  IN 411026
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-23
Decision Date2020-02-27

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