The Simple Locking Intramedullary (Slim) System

Rod, Fixation, Intramedullary And Accessories

Pega Medical Inc.

The following data is part of a premarket notification filed by Pega Medical Inc. with the FDA for The Simple Locking Intramedullary (slim) System.

Pre-market Notification Details

Device IDK192710
510k NumberK192710
Device Name:The Simple Locking Intramedullary (Slim) System
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant Pega Medical Inc. 111 Autoroute Chomeday Laval,  CA H7w55j8
ContactAriel R. Dujovne
CorrespondentAriel R. Dujovne
Pega Medical Inc. 111 Autoroute Chomeday Laval,  CA H7w55j8
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-27
Decision Date2020-06-24

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