Pitkar External Fixation System

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

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 External Fixation System.

Pre-market Notification Details

Device IDK190486
510k NumberK190486
Device Name:Pitkar External Fixation System
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
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 CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-28
Decision Date2019-10-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.